510(k) Report

510(k) · Cleared

Recalled · 2008

Autopulse Resuscitation System, Model 100

K072527510(k) TraditionalCleared Mar 19, 2008194-day reviewClass II21 CFR 870.5200Recalls 1

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

Zoll Circulation · DRM Compressor, Cardiac, External

Cleared on Mar 19, 2008 after a 194-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 9 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled once.

Decided
Mar 19, 2008
Review
194 days
Class
Class II
Product code
DRM
Recalls
1
Predicates
0

8 later devices descend from it, 2 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2012: 1 descendant cleared2009: 1 descendant cleared2016: 2 descendants cleared2014: 1 descendant cleared2023: 1 descendant cleared, 1 with a Class I recall12018: 1 descendant cleared2021: 1 descendant cleared, 1 with a Class I recall120052010201520202025
  1. This deviceK072527 Autopulse Resuscitation System, Model 100Zoll Circulation · 2008
  2. Descendant · cites it directly · 5 of its ownK090422 LUCAS 2Jolife AB · 2009 · Recalled
  3. Descendant · 2 generations on · 2 of its ownK161768 LUCAS 3 Chest Compression SystemJolife AB · 2016 · Recalled
  4. Descendant · 3 generations on · 1 of its ownK173553 LUCAS 3 Chest Compression SystemJolife AB · 2018
  5. Descendant · cites it directly · 1 of its ownK112998 Autopulse Resuscitation System Model 1000Zoll Circulation · 2012 · Recalled
  6. Descendant · 2 generations on · 0 of its ownK221700 AutoPulse NXT Resuscitation SystemZoll Circulation, Inc. · 2023 · Recalled (Class I)

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2009: 12012: 12014: 12016: 22018: 12021: 12023: 1
2009high 2 (2016) · low 0 (2010)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 8 · See all
  • K090422LUCAS 2Jolife AB · 2009 · cites it directly5descendants
  • K161768LUCAS 3 Chest Compression SystemJolife AB · 2016 · 2 generations on2descendants
  • K173553LUCAS 3 Chest Compression SystemJolife AB · 2018 · 3 generations on1descendant
  • K112998Autopulse Resuscitation System Model 1000Zoll Circulation · 2012 · cites it directly1descendant
  • K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K072527Autopulse Resuscitation System, Model 100Zoll Circulation2008—
+1K090422LUCAS 2Jolife AB20093
+2K161768LUCAS 3 Chest Compression SystemJolife AB20162
+3K173553LUCAS 3 Chest Compression SystemJolife AB2018—
+1K112998Autopulse Resuscitation System Model 1000Zoll Circulation20121
+2K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.2023Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
201410
201620
201810
202111
202311
FIG. 1 — Lineage of K072527, 2008–2023Source: 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.

2 devices in this family have 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 DRM device

  1. #1 K221700 AutoPulse NXT Resuscitation Systemscore -7.5 · 6 generations · Class I recall
  2. #2 Held for the reportin 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? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090422LUCAS 2Jolife AB20095
K112998Autopulse Resuscitation System Model 1000Zoll Circulation20121

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 28, 2008Not classifiedZ-1904-2011OtherComplaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).

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.

  • K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
  • K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLC · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K090422 (Jolife AB, 2009) has gone furthest, with 5 descendants of its own.

How does its category compare?

All DRM devices

DRM Compressor, Cardiac, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DRM

1in 2023

2008: 22009: 12010: 12012: 12014: 12016: 22018: 12021: 12023: 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRM

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

Recalls per year · DRM

1in 2022

2008: 12011: 12012: 12022: 12026 (partial year): 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DRM

690in 2025

2007: 82008: 132009: 92010: 72011: 162012: 4832013: 1,2682014: 6642015: 6742016: 6392017: 6792018: 7832019: 7062020: 8442021: 7552022: 7302023: 7652024: 7102025: 690
2007high 1,268 (2013) · low 7 (2010)2025

MAUDE reports naming product code DRM, 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—08
20082—113
20091—09
20101—07
20110—116
20121—1483
20130—01,268
20141—0664
20150—0674
20162—0639
20170—0679
20181—0783
20190—0706
20200—0844
20211—0755
20220—1730
20231—0765
20240—0710
20250—0690
20260—1—
Cite this page

510(k) Report. “K072527: Autopulse Resuscitation System, Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072527

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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