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

DTA — Predicate Candidate Screening

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

121 daysmedian FDA review time

192 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K163008	CareLink SmartSync Device Manager - Pacing System Analyzer	Medtronic, Inc.	2017-02-28	123	0
K101982	MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M AD	St Jude Medical, Crmd	2010-12-21	160	0
K073230	MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS	Biotronik, Inc.	2007-12-20	35	0
K050884	ADAPTER CABLE	Remington Medical, Inc.	2005-05-19	42	1
K033613	MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER	Biotronik, Inc.	2003-12-08	21	0
K022360	ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ER	Biotronik, Inc.	2003-01-27	192	0
K933069	MODEL EP-2 CLINICAL STIMULATOR	Ep Medical, Inc.	1993-10-21	121	0
K812104	SIEMENS-ELEMA PSA 376	Siemens Corp.	1981-12-02	131	0
K791380	VA 1000	Vitatron Medical BV	1979-09-19	57	0
K790503	CARDIOTEST 2200	Cardiac Pacemakers, Inc.	1979-05-17	65	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