Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

BYZ — Predicate Candidate Screening

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

57 daysmedian FDA review time

102 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K925412	ELECTROMEDICS TISSUE TRAP/ #TT280	Electromedics, Inc.	1993-02-05	102
K913643	MUCOUS SPECIMEN TRAP	Medical Device Inspection Co., Inc.	1991-10-10	57
K902883	TISSUE/POLYP TRAP SYSTEM	Triton Technology, Inc.	1990-09-12	72
K841409	BUSH NECK W/PLUG	Warne Surgical Products, Ltd.	1984-04-18	13
K840253	ONE-WAY AIR VALVE	Delta Medical Industries	1984-04-05	73
K834467	SPECIMEN TRAP	Microvasive	1984-02-17	59
K822556	CRITICAL MEASUREMENT UNIT	Bemis Health Care	1982-10-18	55
K822557	SPECIMEN ADAPTOR	Bemis Health Care	1982-10-18	55
K791847	ASPRI-LUKE	Medical Marketing Group	1979-10-02	13

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