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

American Pharmaseal Div. Ahsc — Predicate Candidate Screening

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

49 daysmedian FDA review time

105 days90th percentile

64clearances measured

K-number	Device	Applicant	Decided	Review days
K874022	PHARMASEAL WOUND IRRIGATION DEVICE	American Pharmaseal Div. Ahsc	1987-12-30	89
K874517	PHARMASEAL RUBBER URETHRAL CATHETER	American Pharmaseal Div. Ahsc	1987-12-03	31
K874045	PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER	American Pharmaseal Div. Ahsc	1987-12-03	59
K873359	AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE	American Pharmaseal Div. Ahsc	1987-11-06	77
K872228	PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM	American Pharmaseal Div. Ahsc	1987-09-04	87
K872917	JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER	American Pharmaseal Div. Ahsc	1987-08-11	15
K871429	ANTIMICROBIAL FOLEY CATHETER	American Pharmaseal Div. Ahsc	1987-08-10	123
K871770	AMERICAN PHARMASEAL WOUND DRESSING	American Pharmaseal Div. Ahsc	1987-06-26	51
K870387	EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE	American Pharmaseal Div. Ahsc	1987-05-08	98
K870977	PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE	American Pharmaseal Div. Ahsc	1987-04-01	22
K870941	PHARMASEAL WOUND CARE DRESSING PAD	American Pharmaseal Div. Ahsc	1987-03-27	18
K870704	CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET	American Pharmaseal Div. Ahsc	1987-03-27	35
K870720	AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE	American Pharmaseal Div. Ahsc	1987-03-17	25
K864397	DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBE	American Pharmaseal Div. Ahsc	1986-12-01	25
K861677	PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT	American Pharmaseal Div. Ahsc	1986-06-16	46
K861165	PHARMASEAL DUAL LUMEN CATHETER	American Pharmaseal Div. Ahsc	1986-05-05	38
K853714	PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA	American Pharmaseal Div. Ahsc	1986-01-13	130
K854232	PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES	American Pharmaseal Div. Ahsc	1985-12-10	50
K854012	AMERICAN PHARMASEAL HUMIDAIR CONDENSER	American Pharmaseal Div. Ahsc	1985-12-03	64
K852491	AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER	American Pharmaseal Div. Ahsc	1985-09-25	105
K853207	PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE	American Pharmaseal Div. Ahsc	1985-09-12	43
K851334	AIRLIFE ELECTRONIC INCENTIVE SPIROMETER	American Pharmaseal Div. Ahsc	1985-08-06	127
K850119	PHARMASEAL EYE PREP TRAY	American Pharmaseal Div. Ahsc	1985-05-09	115
K850265	AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE	American Pharmaseal Div. Ahsc	1985-04-05	72
K850266	AMERICAN PHARMASEAL STERILE I.V. START KIT	American Pharmaseal Div. Ahsc	1985-03-22	58
K842860	AMERICAN PHARMASEAL I.V. START KIT	American Pharmaseal Div. Ahsc	1984-08-30	38
K842542	AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY	American Pharmaseal Div. Ahsc	1984-08-20	49
K841544	AMER. PHARMASEAL SILICONIZED LATEX	American Pharmaseal Div. Ahsc	1984-07-09	84
K842380	PRESSURE RELIEF SEAT CUSHION	American Pharmaseal Div. Ahsc	1984-06-28	10
K842198	AMER. PHARMASEAL NO TOUCH SATIN CATHET	American Pharmaseal Div. Ahsc	1984-06-25	21
K840797	MALE-MALE LUER LOCK CONNECTOR W/ROTA	American Pharmaseal Div. Ahsc	1984-04-24	61
K840394	STOPCOCKS & EXTENSION TUBES	American Pharmaseal Div. Ahsc	1984-03-19	49
K840664	TRACHEOSTOMY CLEANING TRAY	American Pharmaseal Div. Ahsc	1984-03-12	26
K832407	DECUBITUS CARE ABSORBENT DRESSING	American Pharmaseal Div. Ahsc	1984-01-19	182
K832907	INVASIVE MONITORING KITS	American Pharmaseal Div. Ahsc	1984-01-10	134
K832556	NEONATAL LUMBAR PUNCTURE TRAY	American Pharmaseal Div. Ahsc	1983-09-12	42
K831807	CATHETER INSERTION TRAYS, VARIOUS #'S	American Pharmaseal Div. Ahsc	1983-07-18	42
K831729	PERCUTANEOUS CATHETER INSERTION TRAY	American Pharmaseal Div. Ahsc	1983-07-18	48
K831730	CONTINUOUS FLUSH DEVICE	American Pharmaseal Div. Ahsc	1983-07-18	48
K830210	DISPOSABLE PRESSURE TRANSDUCER	American Pharmaseal Div. Ahsc	1983-04-18	84
K830839	AMER. 400 SERIES TEMP. PROBES-RECTALL	American Pharmaseal Div. Ahsc	1983-04-06	21
K822811	CONTAINERS OF STERILE WATER OS SALINE	American Pharmaseal Div. Ahsc	1982-10-27	37
K822443	NASO-GARD NASOGASTRIC TUBE HOLDER	American Pharmaseal Div. Ahsc	1982-09-02	17
K821894	DISPOSABLE TRANSDUCER DOMES & KITS	American Pharmaseal Div. Ahsc	1982-07-20	22
K820369	SUCTION CATHETERS & KITS	American Pharmaseal Div. Ahsc	1982-04-16	66
K820370	NASAL OXYGEN CATHETER	American Pharmaseal Div. Ahsc	1982-04-16	66
K820371	PLASTIC CONNECTORS	American Pharmaseal Div. Ahsc	1982-04-01	51
K820412	AM. PH. STERILE PLASTIC CONNECTING TUBES	American Pharmaseal Div. Ahsc	1982-03-31	47
K820420	AM. PH. STERILE FEEDING TUBE	American Pharmaseal Div. Ahsc	1982-03-23	35
K820419	AM. PH. STERILE SINGLE-USE URETHRAL CATH	American Pharmaseal Div. Ahsc	1982-03-23	35

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