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

North American Sterilization & Packaging Co. — Predicate Candidate Screening

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

153 daysmedian FDA review time

393 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K964231	NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)	North American Sterilization & Packaging Co.	1997-03-10	138
K963753	NASP TRANSPARENT DRESSING	North American Sterilization & Packaging Co.	1996-11-29	72
K962352	HYDROGEL SKIN DRESSING	North American Sterilization & Packaging Co.	1996-08-02	45
K925593	NORTEC STERILE WATER FOR DEVICE IRRIGATION	North American Sterilization & Packaging Co.	1993-12-03	393
K925588	NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI	North American Sterilization & Packaging Co.	1993-12-03	393
K925161	NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO	North American Sterilization & Packaging Co.	1993-07-21	281
K911865	NORTEC CONNECTING TUBE SET	North American Sterilization & Packaging Co.	1991-11-01	189
K911784	NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY	North American Sterilization & Packaging Co.	1991-09-23	154
K910691	NORTEC URETERAL STENT	North American Sterilization & Packaging Co.	1991-08-15	177
K903156	CONTROL-TIP CYSTOSCOPIC ELECTRODES	North American Sterilization & Packaging Co.	1990-12-18	153
K903162	FLEXIBLE ENDOSCOPIC ELECTRODES	North American Sterilization & Packaging Co.	1990-12-18	153
K902763	STERILE INSTRUMENT DRAPE	North American Sterilization & Packaging Co.	1990-09-20	87
K900401	NAS&P GRASPING FORCEPS & ASSOC. DEVICES	North American Sterilization & Packaging Co.	1990-02-09	11
K896821	OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE	North American Sterilization & Packaging Co.	1990-02-09	67
K894939	PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY	North American Sterilization & Packaging Co.	1989-12-08	127
K894986	3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET	North American Sterilization & Packaging Co.	1989-12-01	115

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