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

American Convertors Div., American Pharmaseal · Predicate Candidate Screening

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

36 daysmedian FDA review time

76 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K840957	ANTIMICROBIAL INCISE DRAPE	American Convertors Div., American Pharmaseal	1984-06-07	93
K832137	CONVERTORS FLASH STERILIZING TRAY	American Convertors Div., American Pharmaseal	1983-08-12	42
K830786	DISIMETRIC RELEASE OF INSTRANETICS RAD	American Convertors Div., American Pharmaseal	1983-05-18	68
K820994	ABSORB FURN SHEET	American Convertors Div., American Pharmaseal	1982-05-13	35
K813419	COMFORT CUSHION DRY BURN PAD III	American Convertors Div., American Pharmaseal	1982-01-22	46
K813296	CONVERTORS STERILE DISP. LAP SPONGE II	American Convertors Div., American Pharmaseal	1981-12-29	36
K813078	CONTURA DISPOS. SURG. FACE MASK	American Convertors Div., American Pharmaseal	1981-12-18	46
K812554	TOMAC STERILE DISP. LAP SPONGE	American Convertors Div., American Pharmaseal	1981-09-24	16
K802919	ISO-BAC INSTRUMENT WRAP	American Convertors Div., American Pharmaseal	1981-02-02	76
K802998	PATIENT CARE DISPOSABLE INFANT SHIRTS	American Convertors Div., American Pharmaseal	1980-12-22	27
K802317	COMFORT CUSHION DRY BURN PADS, STERILE	American Convertors Div., American Pharmaseal	1980-10-31	38
K802359	DISP. FENESTRATED SURG. DRAPE SHEETS	American Convertors Div., American Pharmaseal	1980-10-31	35
K802050	TACKMER INCISE DRAPE	American Convertors Div., American Pharmaseal	1980-09-16	22
K801568	SHIELD DISPOSABLE BLOOD PRESSURE CUFF	American Convertors Div., American Pharmaseal	1980-07-28	20
K801569	VAL-U-WRAP CSR WRAP	American Convertors Div., American Pharmaseal	1980-07-28	20
K801570	SHIELD DISP. PATIENTS PONCHO GOWNS	American Convertors Div., American Pharmaseal	1980-07-28	20
K800817	SHIELD DISP. REINFORCED DRAPE SHEETS	American Convertors Div., American Pharmaseal	1980-05-02	21
K800511	SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP	American Convertors Div., American Pharmaseal	1980-04-16	42
K800528	SHIELD PERFECT FIT; DURA-FIT, DISPOS.	American Convertors Div., American Pharmaseal	1980-04-16	40

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