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

North American Instrument Corp. · Predicate Candidate Screening

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

72 daysmedian FDA review time

235 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K960801	SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)	North American Instrument Corp.	1996-03-29	31	0
K955554	HEMO-VALVE	North American Instrument Corp.	1996-03-04	90	0
K960310	EPIC INTRODUCER SHEATH	North American Instrument Corp.	1996-02-07	16	0
K922552	MORSE(R) ANGIOGRAPHIC CATHETERS	North American Instrument Corp.	1993-03-03	278	0
K915078	MORSE HEMOSTATIC CATHETER INTRODUCER SET	North American Instrument Corp.	1992-06-10	215	0
K905208	MORSE ANESTHESIA	North American Instrument Corp.	1992-01-10	416	0
K912961	MORSE VASCULAR INTRODUCER SET	North American Instrument Corp.	1991-09-11	65	0
K910764	THE PERCEPTOR(TM) STAND ALONE TRANSDUCER	North American Instrument Corp.	1991-04-22	81	1
K903493	NAMIC CONTRAST SAVINGS DELIVERY SYSTEM	North American Instrument Corp.	1991-03-26	235	0
K904275	MORSE BALLOON INFLATION DEVICE	North American Instrument Corp.	1991-01-03	107	0
K903606	GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER	North American Instrument Corp.	1990-09-27	59	0
K902472	MORSE DT MANIFOLD	North American Instrument Corp.	1990-08-23	80	2
K900652	NAMIC PTCA Y-ADAPTOR	North American Instrument Corp.	1990-06-26	137	0
K896087	PALESTRANT IRRIGATION AND DRAINAGE SET	North American Instrument Corp.	1989-11-03	15	0
K890580	LIPID STOPCOCK	North American Instrument Corp.	1989-04-19	72	0
K885090	HOMER MAMMALOK LOCALIZATION SHIELD	North American Instrument Corp.	1989-02-14	64	0
K884408	NAMIC DUAL BACKCHECK VALVE	North American Instrument Corp.	1989-01-12	85	0
K873955	NAMIC ANGIOGRAPHIC SYRINGE	North American Instrument Corp.	1988-02-05	130	1
K873954	NAMIC HAWKINS UNIVERSAL DRAINAGE SET	North American Instrument Corp.	1988-01-29	123	0
K871377	NAMIC COURNAND STYLE INTRODUCER NEEDLE	North American Instrument Corp.	1987-05-07	30	0
K871378	NAMIC SELDINGER INTRODUCER NEEDLE	North American Instrument Corp.	1987-05-06	29	0
K871382	NAMIC ONE PART INTRODUCER NEEDLE	North American Instrument Corp.	1987-05-06	29	0
K864800	NAMIC CHIBA ASPIRATION BIOPSY NEEDLE	North American Instrument Corp.	1987-02-06	59	0
K852402	NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER	North American Instrument Corp.	1985-07-11	35	0
K852140	NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)	North American Instrument Corp.	1985-05-30	14	3
K842829	HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS	North American Instrument Corp.	1984-10-18	90	0
K843726	NAMIC ADB ANGIOGRAPHIC DUMP BAG	North American Instrument Corp.	1984-10-18	24	0
K833271	NAMIC CONTINUOUS FLUSH DEVICE	North American Instrument Corp.	1983-12-01	71	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