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

Medtronic Physio-Control Corp. — Predicate Candidate Screening

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

149 daysmedian FDA review time

231 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K040775	LIFEPAK 12	Medtronic Physio-Control Corp.	2004-04-23	28	1
K033275	LIFEPAK 12, 20, 500, CR PLUS	Medtronic Physio-Control Corp.	2003-11-06	27	0
K022732	INFANT/CHILD REDUCED ENERGY ELECTRODES	Medtronic Physio-Control Corp.	2002-12-13	119	2
K012274	MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PA	Medtronic Physio-Control Corp.	2002-02-05	201	17
K011144	LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR	Medtronic Physio-Control Corp.	2001-12-03	231	9
K012428	MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATO	Medtronic Physio-Control Corp.	2001-09-28	59	2
K010918	LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM	Medtronic Physio-Control Corp.	2001-08-23	149	4
K002445	LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES	Medtronic Physio-Control Corp.	2001-01-31	175	1

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