510(k) Report

510(k) · Cleared

Recalled · 2008

Low Energy DC - Defibrillator (Including Paddles)

K895379510(k) TraditionalCleared Feb 26, 1990180-day reviewClass II21 CFR 870.5300Recalls 1

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

Physio-Control Corp. · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

Cleared on Feb 26, 1990 after a 180-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled once.

Decided
Feb 26, 1990
Review
180 days
Class
Class II
Product code
LDD
Recalls
1
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK895379 Low Energy DC - Defibrillator (Including Paddles)Physio-Control Corp. · 1990
  2. Descendant · cites it directly · 1 of its ownK182503 Sterilizable Internal Defibrillation Paddles for use with LIFEPAK…Physio-Control, Inc. · 2019 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK203231 Switched Internal PaddlesPhilips North America, LLC · 2021

Most influential descendants

Showing 2 of 2 · See all
  • K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc. · 2019 · cites it directly1descendant
  • K203231Switched Internal PaddlesPhilips North America, LLC · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K895379Low Energy DC - Defibrillator (Including Paddles)Physio-Control Corp.1990—
+1K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK…Physio-Control, Inc.20191
+2K203231Switched Internal PaddlesPhilips North America, LLC2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202110
FIG. 1 — Lineage of K895379, 1990–2021Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LDD? 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 LDD device

  1. #1 K200849 Tempus LS - Manualscore 1.3 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.20191

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 29, 2008Not classifiedZ-2035-2008Labeling designBased on testing, sterilization methods described in labeling may be ineffective and may cause damage or corrosion to the paddles or handles. If handles and/or paddles are not sterilized adequately and are used on a patient, there is a…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K182503 (Physio-Control, Inc., 2019) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LDD devices

LDD Dc-Defibrillator, Low-Energy, (Including Paddles): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LDD

1in 2021

2008: 22010: 22011: 42014: 12015: 12019: 12020: 12021: 1
2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LDD

124in 2011

2011: 124 days median
2007high 124 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LDD

2in 2024

2008: 112009: 12011: 12014: 2, 2 Class I2020: 12022: 12024: 2
2007high 11 (2008) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LDD

74in 2025

2007: 5502008: 1,2142009: 1,0572010: 6352011: 3862012: 3982013: 6022014: 4812015: 862016: 582017: 492018: 282019: 342020: 192021: 222022: 802023: 2642024: 1602025: 74
2007high 1,214 (2008) · low 19 (2020)2025

MAUDE reports naming product code LDD, 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
20070—0550
20082—111,214
20090—11,057
20102—0635
201141241386
20120—0398
20130—0602
20141—2 (2)481
20151—086
20160—058
20170—049
20180—028
20191—034
20201—119
20211—022
20220—180
20230—0264
20240—2160
20250—074
20260—0—

More from Physio-Control Corp.

80 FDA decisions under this applicant name. See the company

  • K991910Lifepak 12 BiphasicPhysio-Control Corp. · 19993 recalls
  • K990338Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor SystemPhysio-Control Corp. · 19991 recall
  • K983393Lifepak 500 BiphasicPhysio-Control Corp. · 19991 recall
  • K973486Life Pak 12Physio-Control Corp. · 19983 recalls
  • K962359Lifepak 300Physio-Control Corp. · 1997

Recent decisions in LDD

The LDD category page

  • K203231Switched Internal PaddlesPhilips North America, LLC · 2021
  • K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 20204 recalls
  • K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc. · 20191 recall
  • K150349Rapid Hair Removal PadsFull Power Aed · 2015
  • K140502Zoll E Series AlsZOLL Medical Corporation · 2014

https://510kreport.com/device/K895379 · printed Nov 6, 2026

Cite this page

510(k) Report. “K895379: Low Energy DC - Defibrillator (Including Paddles).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895379

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026