Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

IYM — Predicate Candidate Screening

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

41 daysmedian FDA review time

211 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K863736	FMS MODEL 110	Flir Medical Systems	1986-12-29	97
K852950	VISITHERM	C.D. Regelin & Associates, Inc.	1986-02-07	211
K823041	JEOL MODEL #JTG-500M	Jeol	1982-11-24	41
K812799	DCATS	Dorex, Inc.	1981-10-20	14
K812701	ORTHO-THERM INFRARED SENSOR	Orthion Corp.	1981-10-13	20
K801553	THERMOCOMP	Hospital Financial Corp.	1980-10-31	115
K800491	GRAPHIC STRESS TELETHERMOMETRY	Gst Laboratories of Ca, Inc.	1980-03-04	0
K760999	THERMOGRAPH, MEDICAL	Honeywell, Inc.	1976-11-19	11

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