510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945511Substantially Equivalent

Lifepak 10 Defibrillator/monitor/pacemaker, and Lifepak 11 Cardiac Monitor

Physio Control, Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945511 is the FDA 510(k) clearance record for LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR, a class II device, cleared for Physio-Control Corp. on under FDA product code MPE (Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker). FDA records list 108 510(k) clearances for Physio-Control Corp., from to . As of , FDA records show no recalls naming K945511.

Clearance record

Decision date
Received
(321 days to decision)
Product code
MPE Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker
Regulation
21 CFR 870.5550
Device class
Class II
Review panel
Cardiovascular
Applicant
Physio-Control Corp. 11811 Willows Rd., NE, Redmond WA
510(k) summary
Summary
Third party review
No

Clearances, product code MPE

Trailing 12 months

FDA records hold no clearances under product code MPE in the trailing twelve months.

FDA records show no clearances under product code MPE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MPE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260