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

Lake Medical Products, Inc. · Predicate Candidate Screening

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

77 daysmedian FDA review time

241 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K943162	LAKE STAGEZERO(TM) AIR FLOTATION BED	Lake Medical Products, Inc.	1995-02-27	241
K922730	LAKE OSTOMY CARE SET	Lake Medical Products, Inc.	1993-12-30	573
K905053	STAGE ZERO AIR FLOTATION BED	Lake Medical Products, Inc.	1990-11-26	18
K901835	LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)	Lake Medical Products, Inc.	1990-09-05	139
K902508	LAKE MALE EXTERNAL CATHETERIZATION KIT	Lake Medical Products, Inc.	1990-08-23	79
K902121	LAKE GASTROSTOMY TUBE	Lake Medical Products, Inc.	1990-07-27	77
K884127	LAKE N/G FEEDING TUBE	Lake Medical Products, Inc.	1989-02-08	131
K884128	LAKE N/G EXTENSION SET	Lake Medical Products, Inc.	1988-12-08	69
K883610	LAKE FOLEY CATHETERIZATION TRAY	Lake Medical Products, Inc.	1988-10-12	51
K880578	LAKE DISPOSABLE PROBE COVER	Lake Medical Products, Inc.	1988-03-31	50
K875383	LAKE CATHETER CARE KITS (MODIFICATION)	Lake Medical Products, Inc.	1988-03-09	85
K873991	LAKE IRRIGATION TRAY	Lake Medical Products, Inc.	1987-12-30	90
K873973	LAKE WOUND CARE/TREATMENT KIT	Lake Medical Products, Inc.	1987-11-20	52
K872750	LAKE CATHETER CARE KIT	Lake Medical Products, Inc.	1987-09-03	52
K872244	CORD-ASSURE UMBILICAL BLOOD GAS KIT	Lake Medical Products, Inc.	1987-07-21	40

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