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

Baxter Edwards — Predicate Candidate Screening

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

148 daysmedian FDA review time

176 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K993816	BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MO	Baxter Edwards	2000-05-04	176	0
K981909	BAXTER HEMOSTASIS VALVE INTRODUCERS	Baxter Edwards	1998-11-24	176	3
K980487	CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS	Baxter Edwards	1998-07-07	148	0
K965137	FOGARTY VALVULOTOME MODEL 700091	Baxter Edwards	1997-06-04	163	0
K964021	INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 7000	Baxter Edwards	1997-03-27	171	0
K955839	MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER	Baxter Edwards	1996-03-25	90	1
K952638	4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTL	Baxter Edwards	1995-07-28	49	0
K944214	BAXTER HANDLE MODEL 1150	Baxter Edwards	1995-02-10	165	0
K944858	BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS	Baxter Edwards	1995-01-05	94	0
K940795	SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER	Baxter Edwards	1994-05-24	91	2
K926433	4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45	Baxter Edwards	1993-03-23	90	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