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

BSS · Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

143 daysmedian FDA review time

567 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K142483	TurboSEAL Nasogastric Aspiration Tube	Turboseal, L.P.	2014-12-19	106
K051480	ENTERAL FEEDING TUBE	Biosearch Medical Products, Inc.	2005-10-12	131
K984629	MOSS TUBES, INC. NASAL TUBE - MARK IV	Moss Tubes, Inc.	1999-03-02	62
K961711	ASPISAFE GASTRIC TUBE	B.Braun Medical, Inc.	1997-06-11	405
K933596	GASTRIC, CATHETER, IRRIGATION & ASPIRATION	Polamedco, Inc.	1995-02-13	567
K930510	RADIUS ENTERAL FEEDING TUBE	Radius Intl., Inc.	1995-02-01	730
K935688	AN-10S ANDERSEN TUBE WITH STYLET	H.W. Andersen Products, Inc.	1994-12-30	396
K934348	TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32F	Tri-Med Specialties, Inc.	1994-12-23	472
K905573	XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A	Zeon Medical Corp.	1991-06-19	189
K910479	ARGYLE POLYURETHANE SALEM SUMP TUBE	Sherwood Medical Co.	1991-04-19	72
K894870	WILTEK NASAL BILIARY DRAINAGE SET	Wiltek Medical, Inc.	1989-12-21	143
K891187	TECNOL NASO-GASTRIC TUBE HOLDER	Tecnol New Jersey Wound Care, Inc.	1989-05-30	85
K791531	FLEXIFLO ENTERAL PUMP SET	Abbott Laboratories	1979-09-12	33

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