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

Bip USA, Inc. — Predicate Candidate Screening

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

138 daysmedian FDA review time

233 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K024089	VACUFLASH BIOPSY SYSTEM	Bip USA, Inc.	2003-03-11	90	0
K934371	BIP MULTI MODIFICATION	Bip USA, Inc.	1994-04-28	233	0
K934370	BIP BIOPSY NEEDLE MODIFICATION	Bip USA, Inc.	1994-03-07	181	5
K935457	LOCALIZATION WIRE OR MARKER - SURGICAL	Bip USA, Inc.	1994-02-17	97	1
K925870	SPACER	Bip USA, Inc.	1993-05-19	181	0
K925875	HORIZONTAL NEEDLE GUIDE ATTACHMENT	Bip USA, Inc.	1993-04-06	138	0
K925874	BREAST STABILIZER	Bip USA, Inc.	1993-03-16	117	0

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