Hopestone FDA 510(k) Intelligence Analyzer

Load Saved Analyses

Saved configurations are stored only in this browser on this device. Loading an analysis reruns it against the current FDA data.

Applicant / company

Company grouping

Save the selected FDA applicant names as a reusable normalized company group.

Saved company group

Group name

Device name

510(k) number

Product code

Decision

Decision date from

Decision date to

Maximum records

Company benchmarking

Peer comparator group

No recommended comparators available yet

Select up to 8 comparators from the complete recommended list.

Peer suggestions will populate automatically from overlapping FDA product-code activity.

Prior-period comparison

Optional reporting use

The analyzer is primarily intended for clearance-time analysis, comparable-device research, and company benchmarking. The final refined results can also be used to create an optional Management Review-ready summary.

Benchmarking uses the FDA applicant names selected above. When enabled, the prior period uses an equal number of calendar days immediately before the current period.

Searches the openFDA Device 510(k) Clearances endpoint and combines the selected FDA applicant names while preserving each original applicant value.

Company alias administration

Normalized company

FDA applicant alias

Prototype aliases are stored only in this browser using local storage. A later server-backed version will add authorization and audit history.

Device group rules

FDA product code

Assign group

Product-code rules override keyword classification and are saved in this browser. Each result shows whether its group came from a product-code rule or keyword logic.

Search FDA 510(k) clearances and measure elapsed time to decision

Use public FDA data to review prior submissions, evaluate company performance, and build a comparable-device dataset. Version 1 calculates total calendar days from FDA receipt to decision; it does not separate FDA review time from applicant hold time.

FDA data sourceopenFDA Device 510(k) Clearances API

Retrieval modeLive query at time of analysis

Last successful queryNot yet run

Most recent decision in resultsNot yet available

Important: Elapsed time is calculated from FDA receipt date to FDA decision date and may include applicant response or hold time. Historical performance does not predict future clearance. Similar-device and peer recommendations require professional regulatory review.

Verification & diagnostics

Repeatable checks for core calculations, browser storage, required controls, export functions, and optional live FDA connectivity.

Check	Status	Expected	Observed / Notes
Run diagnostics to begin.

FDA records returned0

Valid timing records0

Median elapsed days—

Mean elapsed days—

Range—

Clearance Intelligence Analysis

Trend chart style

Matching submissions0

Valid timing records0

10th percentile—

Median elapsed days—

90th percentile—

Clearance years—

Analysis scope

Data quality review

Select a nonzero issue count to review the affected submissions.

Submission-type performance summary

Submission type	Clearances	Mean days	Median days	10th %	90th %

Device-group performance summary

Device group	Clearances	Mean days	Median days	First year	Latest year

FDA panel / specialty summary

Panel / specialty	Clearances	Mean days	Median days	Share

Analysis methodology

Annual median and three-year rolling trend

Annual submission volume

Annual trend detail

Year	Clearances	Mean days	Median days	Std. dev.	Min	Max	25th %	75th %	3-year count	3-year rolling median

Submission-type trend by year

Product-code summary

Product code	Panel	Clearances	First year	Latest year	Mean days	Median days	Min	Max	Example device

Select a product code to review the underlying submissions.

Clearance-time extremes

The shorter-duration and longer-duration groups are based on the current population's 10th and 90th percentiles.

FOIA	Group	510(k)	Device	Applicant	Product code	Type	Decision date	Elapsed days

Annual metrics use the currently filtered and included population. Years with small record counts can be strongly influenced by individual submissions. The three-year rolling median is shown to reduce single-year volatility.

Company benchmark

Current-period median—

Prior-period median—

Peer median—

Change vs prior—

Population	Included	Median days	Mean days	Range	Invalid dates	Filtered / removed

Refine generated benchmark

Use these filters after the benchmark is generated. Metrics and Management Review outputs update dynamically from the remaining records.

Device-name keyword

Product code

Population

Minimum elapsed days

Maximum elapsed days

Review comparison records

Include	FOIA	Population	510(k)	Device	Applicant	Product code	Decision date	Elapsed days	Type	Device group

Up to approximately 10 comparison records are visible at once. Scroll within the list to review additional records.

Unchecked records are removed only from the current on-screen benchmark calculation; the underlying FDA source data are not changed. Lower elapsed time may be favorable, but it does not independently demonstrate better submission quality. Differences may reflect device complexity, portfolio mix, FDA review conditions, applicant response time, or other factors.

Refine by device-name keyword

Decision date from

Decision date to

Candidate devices0

Selected devices0

Selected median days—

Strong structured matches0

Compare	FOIA	Score	510(k)	Device	Applicant	Product code	Regulation	Type	Device group	Decision date	Elapsed days	Why matched

Similarity is based on available public fields. Users remain responsible for evaluating intended use, technological characteristics, predicate eligibility, current marketing status, and other substantial-equivalence considerations.

Filter available records

No 510(k) records selected.

Select	510(k)	Device	Applicant	Product code	Decision date

FDA recipient (pre-populated)

For 510(k) records, the request is directed to CDRH. FDA currently recommends submitting FOIA requests through its online portal for timely logging.

Requester name

Capitalization is standardized when you leave the field.

Organization

Telephone

US telephone numbers are formatted automatically while typing.

Mailing address

The separate address fields enable browser address suggestions and autofill as you type. The address is standardized when you leave a field.

Remember my requester information on this device

When enabled, requester details are stored only in this browser on this device and are automatically restored when the FOIA window opens.

Requested FDA record categories

Preferred delivery format

Fee limit

Request advance notice before fees exceed this amount.

Additional requested records or instructions

After selecting Generate FOIA request, choose Microsoft Word, Google Docs-compatible, or plain-text output. The completed request will be generated and downloaded immediately.

FDA may redact, withhold, or be unable to locate requested records. The generated request should be reviewed before submission and should not include unnecessary confidential or sensitive information.

FOIA	Similar device	510(k)	Device	Original applicant	Normalized company	Product code	Receipt date	Decision date	Elapsed days	Decision result	Type	Type source	Device group	Group confidence	Classification basis	Summary / statement	FDA record

Median is calculated from all returned records with valid receipt and decision dates. For an even number of records, the median may end in .5 days. Historical elapsed time does not predict future clearance time. A similar device is not automatically an acceptable predicate. Public FDA data may be incomplete or inconsistent and should be verified against the FDA source before regulatory or management decisions are made.

Enter search criteria and select Search FDA.

FDA 510(k) Intelligence Analyzer