510(k) Report

510(k) · Cleared

Cleared

Defibrillator Interal Paddle Test Load

K790394510(k) TraditionalCleared Mar 23, 197925-day reviewClass II21 CFR 870.5325

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

Physio-Control Corp. · DRL Tester, Defibrillator

Cleared on Mar 23, 1979 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Mar 23, 1979
Review
25 days
Class
Class II
Product code
DRL
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared19801990200020102020
  1. This deviceK790394 Defibrillator Interal Paddle Test LoadPhysio-Control Corp. · 1979
  2. Descendant · cites it directly · 0 of its ownK061606 Defibrillator Cable Tester, Model DT2200Medical Devices/Padpro, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K061606Defibrillator Cable Tester, Model DT2200Medical Devices/Padpro, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K790394Defibrillator Interal Paddle Test LoadPhysio-Control Corp.1979—
+1K061606Defibrillator Cable Tester, Model DT2200Medical Devices/Padpro, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K790394, 1979–2006Source: 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 DRL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (1)

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

NumberDeviceApplicantDecidedDescendants
K061606Defibrillator Cable Tester, Model DT2200Medical Devices/Padpro, Inc.20060

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K061606 (Medical Devices/Padpro, Inc., 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DRL devices

DRL Tester, Defibrillator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRL

1in 2019

2007: 12008: 22011: 12015: 12018: 12019: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRL

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

Recalls per year · DRL

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRL

2in 2013

2009: 12013: 2
2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code DRL, 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
20082—00
20090—01
20100—00
20111—00
20120—00
20130—02
20140—00
20151—10
20160—00
20170—00
20181—00
20191—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
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 DRL

The DRL category page

  • K190437Delta 3300Netech Corporation · 2019
  • K182905UniPulseSeaward Group · 2018
  • K153210Defibrillator Analyzer Variable LoadBc Group International, Inc. · 2015
  • K110192Defibrillator Analyzer - DA-2006PBc Group International, Inc. · 20111 recall
  • K083347Impulse 7010 Defibrillator Selectable LoadsFluke Biomedical · 2008

https://510kreport.com/device/K790394 · printed Nov 6, 2026

Cite this page

510(k) Report. “K790394: Defibrillator Interal Paddle Test Load.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790394

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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