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

Angeion Corp. — Predicate Candidate Screening

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

136 daysmedian FDA review time

339 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K921757	ANGEION IGITAL ANGEFLATOR	Angeion Corp.	1993-03-18	339	0
K925533	ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET	Angeion Corp.	1993-01-12	71	0
K915719	ANGEION ENDOSCOPIC VALVE SEAL	Angeion Corp.	1992-02-18	60	0
K902377	ANGEFLATOR(TM)	Angeion Corp.	1990-12-13	197	0
K895580	Y-ADAPTER W/THOUY BORST	Angeion Corp.	1990-04-30	227	0
K894446	ANGEION HEMOSTASIS VALVE INTRODUCER	Angeion Corp.	1989-11-30	136	1
K871153	CATHETER INTRODUCER	Angeion Corp.	1987-06-24	92	2

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