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

FRL — Predicate Candidate Screening

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

39 daysmedian FDA review time

244 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K121898	STAY FRESH SKIN FOLD MANAGEMENT TEXTILE	Quick-Med Technologies, Inc.	2013-05-24	329
K110715	INTERDRY SILVER	Milliken Healthcare Products, LLC	2011-11-04	234
K061615	INTERDRY TEXTILE WITH SILVER	Milliken Chemical	2006-12-22	196
K931626	CARAPACE STERILE COTTON BALLS	Carapace, Inc.	1993-12-02	244
K914081	ICAN COTTON RAYON BALLS	Icn Pharmaceuticals, Inc.	1991-10-09	28
K811990	TRACH CLEANING TRAY	Associated Medical Products Co.	1981-07-27	14
K810242	UTENSIL & PROCEDURE TRAYS	American Hospital Supply Corp.	1981-04-15	77
K800277	MEDSPEC RAYON BALLS	Medspec Corp.	1980-03-12	36
K800248	SURGITEK FOERSTER FACE LIFT BANDAGE	Medical Engineering Corp.	1980-02-19	13
K800249	SURGITEK FOERSTER MAMMARY BANDAGE	Medical Engineering Corp.	1980-02-19	13
K792295	SORBIES	American Hospital Supply Corp.	1979-12-20	37
K792294	BREAST PAD	American Hospital Supply Corp.	1979-12-11	28
K791167	DEXIDE DISPOSABLE PREP PAD	Dexide, Inc.	1979-08-03	39
K780974	BACILLUS PUMILUS	Urol, Inc.	1978-07-27	48
K771712	CATHETER DRESSING CHANCE SET	Shield Laboratories, Inc.	1977-10-13	31
K771551	I.V. PREP & CARE KIT	Jelco Laboratories	1977-10-04	53
K770853	STERILE COTTON	Stat Medical Corp.	1977-05-23	14
K770588	COTTON BALL KIT	American Hospital Supply Corp.	1977-05-23	56
K761099	DOVER HYPERALIMENTATION DRESSING CHNG KT	Will Ross Co.	1977-01-28	67

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