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

Cox Medical Ent., Inc. — Predicate Candidate Screening

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

70 daysmedian FDA review time

130 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K946360	MODULAR BIOPSY FORCEP	Cox Medical Ent., Inc.	1995-03-06	66
K950689	UCB	Cox Medical Ent., Inc.	1995-03-06	20
K941464	BASICS ENDOSCOPY SYSTEM	Cox Medical Ent., Inc.	1994-08-05	130
K940911	BASICS ENDOSCOPY SYSTEM	Cox Medical Ent., Inc.	1994-05-16	80
K932790	THERMAL OPTION	Cox Medical Ent., Inc.	1994-01-28	233
K935250	ACCU-PATH	Cox Medical Ent., Inc.	1994-01-21	81
K924655	COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2)	Cox Medical Ent., Inc.	1992-12-15	91
K923671	COX DISPOSABLE POLYPECTOMY SNARES	Cox Medical Ent., Inc.	1992-10-13	83
K923672	COX DISPOSABLE ENDOSCOPE CLEANING BRUSH	Cox Medical Ent., Inc.	1992-09-23	63
K923489	COX DISPOSABLE RETRIEVAL DEVICES	Cox Medical Ent., Inc.	1992-09-23	70
K914466	COX DISPOSABLE CYTOLOGY BRUSHES	Cox Medical Ent., Inc.	1991-10-25	18
K914442	COX DISPOSABLE ENDOSCOPE CLEANING BRUSH	Cox Medical Ent., Inc.	1991-10-25	21
K913883	COX DISPOSABLE BIOPSY FORCEP	Cox Medical Ent., Inc.	1991-10-05	37
K912407	COX DISPOSABLE CYTOLOGY BRUSHES	Cox Medical Ent., Inc.	1991-09-10	103
K912254	COX DIAPOSABLE POLYPECTOMY SNARE	Cox Medical Ent., Inc.	1991-07-26	66

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