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

American Medical Disposable, Inc. · Predicate Candidate Screening

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

29 daysmedian FDA review time

94 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days
K833734	NEUROLOGICAL SPONGE ON PLASTIC STICK	American Medical Disposable, Inc.	1984-04-23	181
K833735	AN ODOR ABSORBENT BANDAGE	American Medical Disposable, Inc.	1984-04-23	181
K833730	NON ADHERENT BANDAGE/SHEET	American Medical Disposable, Inc.	1984-01-27	94
K833731	BREATHABLE OVERWRAY BANDAGE NON-ELAS	American Medical Disposable, Inc.	1984-01-27	94
K833729	ELASTIC BREATHABLE OVER-WRAP BANDAGE	American Medical Disposable, Inc.	1983-12-30	66
K833733	NON - ADHERENT BANDAGE	American Medical Disposable, Inc.	1983-12-27	63
K833732	NON WETTING UNDERCAST PADDING	American Medical Disposable, Inc.	1983-12-12	48
K830201	POLYESTER X-RAY DETECTABLE STRUNG-SPONGE	American Medical Disposable, Inc.	1983-02-23	34
K830202	COTTON BALLS, X-RAY OPAQUED STRUNG & NON	American Medical Disposable, Inc.	1983-02-23	34
K803116	HEAVY DRAINAGE PACK	American Medical Disposable, Inc.	1981-01-28	49
K803115	DRESSING CHANGE FOR G TUBE	American Medical Disposable, Inc.	1981-01-06	27
K803119	LARGE WOUND DRESSING KIT	American Medical Disposable, Inc.	1980-12-30	20
K803117	CUSTOM DRESSING TRAY WET TO DRY	American Medical Disposable, Inc.	1980-12-23	13
K803114	HYPERALIMENTATION DRESSING CHANGE TRAY	American Medical Disposable, Inc.	1980-12-22	12
K803118	SIMPLE DRESSING TRAY #82028	American Medical Disposable, Inc.	1980-12-22	12
K802383	CUSTOM DRESSING TRAY/CARDINAL CUSHING	American Medical Disposable, Inc.	1980-11-12	41
K802384	CENTRAL VENOUS CATHETER DRESSING TRAY	American Medical Disposable, Inc.	1980-11-12	41
K802385	CUSTOM DRESSING TRAY-WET TO DRY/MASS.	American Medical Disposable, Inc.	1980-11-12	41
K802386	SUTURE WOUND TRAY MILFORD WHITTINSVILLE	American Medical Disposable, Inc.	1980-11-12	41
K802387	MINOR DRESSING TRAY-MILFORD HOSP.	American Medical Disposable, Inc.	1980-11-12	41
K802388	MAJOR DRESSING TRAY-MILFORD HOSP.	American Medical Disposable, Inc.	1980-11-12	41
K800020	NON ADHERANT WOUND BANDAGES	American Medical Disposable, Inc.	1980-01-17	13
K800021	NON ADHERANT NEUROLOGICAL SPONGES	American Medical Disposable, Inc.	1980-01-17	13
K792612	TRACHEOTOMY SPONGE, W/NON-WOVEN NYLON	American Medical Disposable, Inc.	1980-01-09	22
K792613	TRACHEOTOMY SPONGE, NON-ADHERENT	American Medical Disposable, Inc.	1980-01-09	22
K792614	TRACHOETOMY SPONGE, NON-ADHERENT CELL	American Medical Disposable, Inc.	1980-01-09	22
K792615	CELLULOSE TRACHE SPONGE	American Medical Disposable, Inc.	1980-01-09	22
K792616	TRACHEOTOMY SPONGE, NON-ADHERENT W/HDPE	American Medical Disposable, Inc.	1980-01-09	22
K792617	TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER	American Medical Disposable, Inc.	1980-01-09	22
K792618	TRACHEOTOMY SPONGE, NON-WOVEN DELNET	American Medical Disposable, Inc.	1980-01-09	22
K792431	VAGINAL PACKING	American Medical Disposable, Inc.	1979-12-27	29
K792432	TEMPORARY BURN SHEET WITH PERFORATED	American Medical Disposable, Inc.	1979-12-20	22
K792433	TEMPORARY BURN SHEET WITH PERFORATED	American Medical Disposable, Inc.	1979-12-20	22

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