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

Applied Medical Technologies — Predicate Candidate Screening

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

81 daysmedian FDA review time

331 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K971434	A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE	Applied Medical Technologies	1998-08-17	486	0
K972478	PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES	Applied Medical Technologies	1998-02-09	223	0
K973893	AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING D	Applied Medical Technologies	1997-12-19	66	0
K971757	LOW PROFILE FEEDING SET ACCESSORY	Applied Medical Technologies	1997-11-07	178	0
K971758	CAUTERIZATION SMOKE EVACUATOR	Applied Medical Technologies	1997-07-21	69	0
K961345	DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TU	Applied Medical Technologies	1996-09-17	162	0
K960232	ENDOSCOPIC ACCESS DEVICE	Applied Medical Technologies	1996-03-21	64	0
K945618	GASTROINTESTINAL TUBES & ACCESSORIES	Applied Medical Technologies	1995-10-12	331	0
K946140	PRG BUTTON	Applied Medical Technologies	1995-08-28	255	0
K923488	GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY	Applied Medical Technologies	1995-07-20	1100	0
K923692	STOMA MEASURING DEVICE	Applied Medical Technologies	1993-05-07	288	0
K920894	DECOMPRESSION TUBES	Applied Medical Technologies	1992-04-28	67	0
K910584	ONE STEP BUTTON(TM)	Applied Medical Technologies	1991-05-23	101	6
K903036	P.R.G. GUIDEWIRE PLACEMENT SYSTEM	Applied Medical Technologies	1990-11-19	131	0
K900884	P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY	Applied Medical Technologies	1990-07-02	126	0
K901339	BIOPSY FORCEPS (NON-RIGID)	Applied Medical Technologies	1990-06-11	81	0
K895480	BLUNT NEEDLE PORT/I.V. PORT	Applied Medical Technologies	1989-12-01	81	0
K895684	SOFT SUCTION ADAPTER	Applied Medical Technologies	1989-11-20	60	0
K895682	VESSEL LOOPS	Applied Medical Technologies	1989-10-24	33	0
K895683	BERNARD VESSEL APPROXIMATOR	Applied Medical Technologies	1989-10-24	33	0
K895726	VESSEL OCCLUDER	Applied Medical Technologies	1989-10-24	29	0
K895681	CONTRAST BACKGROUND MATERIAL	Applied Medical Technologies	1989-10-24	33	0
K810203	MODEL AM 722	Applied Medical Technologies	1981-02-10	18	0

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