510(k) Report

510(k) · Cleared

Cleared

LIFEPAK® 35 AC Power Adapter (41335-000001)

K240162510(k) TraditionalCleared Apr 19, 202488-day reviewClass II21 CFR 870.5300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Physio-Control · MPD Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator

Cleared on Apr 19, 2024 as substantially equivalent to K142430 (Physio-Control, Inc., 2014) after an 88-day review. Its family tree reaches back 12 generations to 1993. 1 of the 35 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided
Apr 19, 2024
Review
88 days
Class
Class II
Product code
MPD
Recalls
None
Predicates
1

Its longest line of descent runs back 12 generations to K921669 (1993). 33 ancestors in all, the oldest K802288 (1980). 1 later device descends from it, 1 citing it directly. 1 of the 35 devices in this family, counting this one, has a Class I recall.

  1. Root · 12 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
  2. 8 generations between
  3. 3 generations backK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
  4. 2 generations backK103567 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011
  5. 1 generation backK142430 LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · Recalled (Class I)
  6. This deviceK240162 LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control · 2024
  7. Descendant · cites it directly · 0 of its ownK253099 LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc. · 2025
Show all 12 generations
  1. Root · 12 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
  2. 11 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
  3. 10 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
  4. 9 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
  5. 8 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
  6. 7 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
  7. 6 generations backK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
  8. 5 generations backK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
  9. 4 generations backK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
  10. 3 generations backK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
  11. 2 generations backK103567 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011
  12. 1 generation backK142430 LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · Recalled (Class I)
  13. This deviceK240162 LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control · 2024

Class I recalls in this family

Most influential descendants

Showing 1 of 1 · See all
  • K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K921669Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc.1993—
−11K964750Eagle 4000 Patient MonitorMarquette Electronics, Inc.1997—
−10K973486Life Pak 12Physio-Control Corp.19983
−9K991910Lifepak 12 BiphasicPhysio-Control Corp.19993
−8K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp.200217
−7K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp.20031
−6K040775Lifepak 12Medtronic Physio-Control Corp.20041
−5K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.2004—
−4K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.20072
−3K082937Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.20093
−2K103567Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.2011—
−1K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc.2014Class I
0 (this device)K240162LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control2024—
+1K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198410
199010
199110
199220
199410
199540
199620
199820
199920
200140

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K240162, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MPD device

  1. #1 K253099 LIFEPAK 15 AC Power Adapter (41577-000333)score 13.8 · 13 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K142430LIFEPAK 15 monitor/defibrillator
Summary page 4
…510(k) Number(s) / Clearance Date LIFEPAK 15 AC Power Adapter, accessory to K142430 / cleared on 12/19/2014 the LIFEPAK 15 Monitor/Defibrillator Device Description: The LIFEPAK 35 AC Power Adapter is an optiona…
Physio-Control, Inc.2014Class I

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc.20250

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls

What does this lineage say?

  • The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
  • 16 of the 33 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K253099 (Physio-Control, Inc., 2025) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MPD devices

MPD Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · MPD

1in 2025

2007: 12024: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MPD

Too few MPD 510(k)s in any year since 2007 to give a median.

Recalls per year · MPD

No recall names MPD since 2007.

Adverse event reports per year · MPD

11in 2025

2011: 12025: 11
2007high 11 (2025) · low 0 (2007)2025

MAUDE reports naming product code MPD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20241—00
20251—011
20260—0—

What is it indicated for?

The LIFEPAK 35 AC power adapter is an optional accessory intended to connect to the LIFEPAK 35 monitor/defibrillator to provide auxiliary power. The bracket and screws provided are intended to attach the power adapter to a wall or shelf.

The LIFEPAK 35 AC power adapter is intended for indoor environments and for fixed installation in ground transportation vehicles.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K240162: LIFEPAK® 35 AC Power Adapter (41335-000001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240162

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026