510(k) Report

FDA applicant

Physio-Control Corp.

Redmond, WA97 decisions1976–202546 recalls

FDA records 97 decisions for Physio-Control Corp. (Redmond, WA) from 1976 to 2025: 94 510(k) clearances and 3 original PMA approvals. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and LDD (Dc-Defibrillator, Low-Energy, (Including…). Its devices cite 57 predicates, 22 of them its own earlier devices. 46 recalls are linked to its devices, 5 Class I.

FDA’s records also spell it “Physio-Control, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Physio-Control Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2008: 12009: 12010: 32011: 12012: 12013: 22014: 12017: 12018: 22019: 12024: 12025: 1
2007high 3 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2026

2007: 12008: 52009: 22010: 32011: 12016: 12017: 5, 3 Class I2019: 4, 2 Class I2020: 12021: 12023: 112024: 22025: 52026 (partial year): 2
2007high 11 (2023) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Physio-Control Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MKJAutomated External Defibrillators (Non-Wearable)21decisions
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)17decisions
  • DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)10decisions
  • DRXElectrode, Electrocardiograph5decisions
  • DPSElectrocardiograph5decisions
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone5decisions

Also: DXN (5), DRT (3), DSF (3), KLA (2), IOL (2), MSX (2).

Whose devices does it build on?

Its devices cite 57 predicates; 22 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 61 times; 22 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K973486Life Pak 12Physio-Control Corp. · 19988cite it
  • K991910Lifepak 12 BiphasicPhysio-Control Corp. · 19998cite it
  • K990338Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor SystemPhysio-Control Corp. · 19996cite it
  • K983393Lifepak 500 BiphasicPhysio-Control Corp. · 19996cite it
  • K955854Lifepak 500Physio-Control Corp. · 19964cite it
  • K912189Likepak 11 Cardiac Monit/Lifenet RS100 Rec StationPhysio-Control Corp. · 19923cite it

What has FDA decided for it lately?

  • K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc. · 2025
  • K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure…Physio-Control, Inc. · 2024
  • K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc. · 20191 recall
  • P170018LIFEPAK® CR2 DefibrillatorPhysio-Control, Inc. · 20182 recalls
  • P160026Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak…Physio-Control, Inc. · 201817 recalls
  • P160012LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery ChargerPhysio-Control, Inc. · 20171 recall
  • K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 20143 Class I recalls
  • K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 20131 Class I recall

All 80 as Physio-Control Corp. →All 17 as Physio-Control, Inc. →

What has been recalled?

46 recalls linked to its devices; the latest:

  • P160026LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241…Apr 13, 2026Class II
  • P160012PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers…Jan 21, 2026Class II
  • P170018LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911…Jul 22, 2025Class II
  • P160026LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 /…Jul 22, 2025Class II
  • P160026LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 /…Jul 22, 2025Class II
  • P160026LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in…Feb 3, 2025Class II

Other applicant names beginning “Physio-Control”

FDA records each applicant name separately; these may or may not be the same firm.

Physio Technology, Inc. 10Physio Systems, Inc. 3Physio Tronics Corp. 1Physio Designs, Inc. 1Physio-Dyne Industrument Corp. 1Physio-Dyne 1Physio-Dyne Instrument Corp. 1Physio, Inc. 1Physio Ventures, Inc. 1