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

FLG — Predicate Candidate Screening

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

89 daysmedian FDA review time

329 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K944950	KLENZYME	Calgon Corp.	1994-12-20	74
K944494	ALSA-KLENZ	Calgon Vestal Div.	1994-10-19	36
K944033	BILL EVANS-KLENZ	Calgon Vestal Div.	1994-10-07	51
K941163	MON-KLENZ	Calgon Vestal Div.	1994-05-18	68
K940263	NPH-KLENZ	Calgon Corp.	1994-05-18	117
K935063	INSTRU KLENZ	Calgon Corp.	1994-05-09	200
K934666	PDS ULTRACLEAN	Medical Polymers, Inc.	1994-04-15	199
K931270	SURGICLEAN ENZYMATIC INSTRUMENT CLEANER	Surgicot, Inc.	1994-04-13	401
K933149	INSTRUMENT DETERGENT CONCENTRATE	Nobelpharma USA, Inc.	1994-02-16	232
K884660	BIOSONIC ULTRASONIC CLEANING SYSTEM	Whaledent Intl. Div. Ipco	1989-03-16	129
K862282	RAPIDEX BIOLOGICAL SURFACTANT	Rapidex of London	1987-05-11	329
K861147	UCS-2, ULTRASONIC CLEANING SOLUTION	Keymed, Inc.	1986-06-23	89
K861592	WEC-WASH, CATALOG NO. 850-115	Palmetto Chemical & Supply Co., Inc.	1986-06-17	49
K861588	WECK INSTRUMENT CLEANER, CAT. NO. 850-103	Palmetto Chemical & Supply Co., Inc.	1986-06-17	49
K861590	WEC-KLEEN, CATALOG N. 850-102	Palmetto Chemical & Supply Co., Inc.	1986-06-17	49
K861587	WECK CONCENTRATED LIQUID CLEANER	Palmetto Chemical & Supply Co., Inc.	1986-05-19	20
K852527	SATALEC SEPTOSONIC SC 80/SC 120	Spelna, Inc.	1986-01-03	203
K842754	CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2	Custom Ultrasonics	1984-11-28	135
K771679	MICROFLATOR	Fisons Corp.	1977-09-28	22

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