510(k) Report

510(k) · Cleared

Cleared

LIFEPAK 15 AC Power Adapter (41577-000333)

K253099510(k) SpecialCleared Oct 14, 202520-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

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

Cleared on Oct 14, 2025 as substantially equivalent to K240162 (Stryker Physio-Control, 2024) after a 20-day review. Its family tree reaches back 13 generations to 1993. 1 of the 35 devices in its family, counting itself, has a Class I recall.

Decided
Oct 14, 2025
Review
20 days
Class
Class II
Product code
MPD
Recalls
None
Predicates
1

Its longest line of descent runs back 13 generations to K921669 (1993). 34 ancestors in all, the oldest K802288 (1980). No later device cites it as a predicate yet. 1 of the 35 devices in this family, counting this one, has a Class I recall.

  1. Root · 13 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
  2. 9 generations between
  3. 3 generations backK103567 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011
  4. 2 generations backK142430 LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · Recalled (Class I)
  5. 1 generation backK240162 LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control · 2024
  6. This deviceK253099 LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc. · 2025
Show all 13 generations
  1. Root · 13 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
  2. 12 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
  3. 11 generations backK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
  4. 10 generations backK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
  5. 9 generations backK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
  6. 8 generations backK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
  7. 7 generations backK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
  8. 6 generations backK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
  9. 5 generations backK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
  10. 4 generations backK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
  11. 3 generations backK103567 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011
  12. 2 generations backK142430 LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · Recalled (Class I)
  13. 1 generation backK240162 LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control · 2024
  14. This deviceK253099 LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc. · 2025

Class I recalls in this family

View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K921669Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc.1993—
−12K964750Eagle 4000 Patient MonitorMarquette Electronics, Inc.1997—
−11K973486Life Pak 12Physio-Control Corp.19983
−10K991910Lifepak 12 BiphasicPhysio-Control Corp.19993
−9K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp.200217
−8K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp.20031
−7K040775Lifepak 12Medtronic Physio-Control Corp.20041
−6K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.2004—
−5K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.20072
−4K082937Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.20093
−3K103567Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.2011—
−2K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc.2014Class I
−1K240162LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control2024—
0 (this device)K253099LIFEPAK 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
FIG. 1 — Lineage of K253099, 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 K240162 LIFEPAK® 35 AC Power Adapter (41335-000001)score 13.5 · 12 generations · no Class I recall
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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
*K240162LIFEPAK® 35 AC Power Adapter (41335-000001)
Summary page 5
…cleared device: Predicate Device 510(k) Number(s) / Clearance Date K240162 / LIFEPAK 35 AC Power Adapter Cleared on 04/19/2024 LIFEPAK 15 AC…
Stryker Physio-Control2024—

What descends from it?

No later submission names this one as a predicate yet.

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 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls

What does this lineage say?

  • The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
  • 16 of the 34 ancestors have a recall of any class; 1 has a Class I recall.

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. 2025, 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 15 AC power adapter is an optional accessory intended to connect to the LIFEPAK 15 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 15 AC Power Adapter is intended for the in-hospital environment and ground transport vehicles.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K253099: LIFEPAK 15 AC Power Adapter (41577-000333).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253099

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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