Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

HCS · Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

69 daysmedian FDA review time

251 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K981805	POS T-7000	Pos Technologies, Inc.	1998-08-07	78
K974208	TYTRON C-3000	Titronics Research & Development Co.	1998-02-03	85
K950986	NEUROREADER	Artronics	1995-11-09	251
K894772	THERMALGRAPHIC ANALYSER	Medtech Instruments	1989-10-03	69
K840487	T-METER	K.J. Electronics	1984-03-12	35
K831995	TRENDO-SCOPE	Gabriel Ent.	1983-08-08	48
K822795	GABRIEL DIGITREND	Gabriel Ent.	1982-10-08	22
K821107	EXOPHTHALMOMETER	Medical Equipment Designs, Inc.	1982-06-14	55

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda