510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130454Substantially Equivalent

Lifepak 20 Defibrillator/monitor, Lifepak 20E Defibrillator/monitor

Physio Control, Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130454 is the FDA 510(k) clearance record for LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR, a class III device, cleared for Physio-Control, Inc. on under FDA product code MKJ (Automated External Defibrillators (Non-Wearable)). FDA's definition for product code MKJ reads: "This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an...". FDA records list 108 510(k) clearances for Physio-Control, Inc., from to . As of , FDA records show one recall naming K130454.

Clearance record

Decision date
Received
(180 days to decision)
Product code
MKJ Automated External Defibrillators (Non-Wearable)
Regulation
21 CFR 870.5310
Device class
Class III
Review panel
Cardiovascular
Applicant
Physio-Control, Inc. 11811 Willows Rd. Northeast, Redmond WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MKJ

Trailing 12 months

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

FDA records show no clearances under product code MKJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MKJ, 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