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

E.M. Adams — Predicate Candidate Screening

21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

54 daysmedian FDA review time

164 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K905173	SPLASH GUARD	E.M. Adams	1991-04-25	160
K910468	STERILE DISPOSABLE DRAPE(S)	E.M. Adams	1991-03-21	45
K873978	DISPOSABLE BIPOLAR FORCEPS	E.M. Adams	1987-11-23	54
K850063	INSTRUMENT POCKET	E.M. Adams	1985-02-21	44
K843724	I.V. START KIT & OBSTETRICAL KIT	E.M. Adams	1985-01-10	108
K843783	WET PACK	E.M. Adams	1984-12-19	84
K843782	DRY TRAY	E.M. Adams	1984-12-13	78
K843723	STERILE INSTRUMENT TRAYS-VARIOUS	E.M. Adams	1984-10-23	29
K843115	STERILE SOLUTION BOWL	E.M. Adams	1984-09-07	30
K843116	DISPOSABLE SKIN MARKING PEN	E.M. Adams	1984-08-17	9
K831841	STERILE DISP. INSTRUMENT TRAYS	E.M. Adams	1983-12-14	190
K832602	THYROID PROTECTIVE COLLAR	E.M. Adams	1983-09-29	58
K832601	LEADED X-RAY APRON	E.M. Adams	1983-09-29	58
K831731	INFANT EVALUATION CARRIER	E.M. Adams	1983-07-18	48
K837085	DOPPLER FOR DETECTING OCCLUSIONS AND TAKING SYSTOLIC BLOOD P	E.M. Adams	1983-05-09	27
K812134	INCISION & DRAINAGE TRAY	E.M. Adams	1982-01-15	171
K812133	WOUND CLOSURE INSTRUMENT TRAY	E.M. Adams	1982-01-08	164
K813260	TRACHEOSTOMY CARE TRAY	E.M. Adams	1981-12-31	41
K812132	STERILE SUTURE REMOVAL KIT	E.M. Adams	1981-12-01	126
K790491	ITIMIZED INSTRUMENTS	E.M. Adams	1979-04-04	27
K780034	AUTOCLAVE POUCHES&ROLLS/STEAM&GAS	E.M. Adams	1978-02-21	43

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