510(k) Report

510(k) · Cleared

Cleared

Thumper, Model: 1008

K073079510(k) TraditionalCleared Feb 14, 2008106-day reviewClass II21 CFR 870.5200

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

Michigan Instruments, Inc. · DRM Compressor, Cardiac, External

Cleared on Feb 14, 2008 as substantially equivalent to K972525 (Michigan Instruments, Inc., 1997) and 1 other predicate after a 106-day review. Its family tree reaches back 5 generations to 1985. 1 of the 14 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.

Decided
Feb 14, 2008
Review
106 days
Class
Class II
Product code
DRM
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K851139 (1985). 7 ancestors in all. 6 later devices descend from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2001: 1 other ancestor2009: 1 descendant cleared2016: 2 descendants cleared2014: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant cleared, 1 with a Class I recall1K851139 · Thumper Cardiopulmonary Resuscitator 1005 · Michigan Instruments, Inc. · 1985K022345 · Autopulse Resuscitation System · Revivant Corp. · 2002 · recalled×2: 2 generations cleared close together, K032852 (2003), K040453 (2004) K063602 · Autopulse Resuscitation System MODEL100 · Zoll Circulation · 2006 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant, 1 with a Class I recall1 K063602 · Autopulse Resuscitation System MODEL100 · Zoll Circulation · 2006 · recalledK040453 · Autopulse Resuscitation System, Model 100 · Revivant Corp. · 2004 · recalledK032852 · Modification to: Autopulse Resuscitation System Model 100 · Revivant Corp. · 2003 · recalledK022345 · Autopulse Resuscitation System · Revivant Corp. · 2002 · recalledK851139 · Thumper Cardiopulmonary Resuscitator 1005 · Michigan Instruments, Inc. · 1985−50
  1. Root · 5 generations backK851139 Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc. · 1985
  2. 4 generations backK022345 Autopulse Resuscitation SystemRevivant Corp. · 2002 · Recalled
  3. 3 generations backK032852 Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 2003 · Recalled
  4. 2 generations backK040453 Autopulse Resuscitation System, Model 100Revivant Corp. · 2004 · Recalled
  5. 1 generation backK063602 Autopulse Resuscitation System MODEL100Zoll Circulation · 2006 · Recalled
  6. This deviceK073079 Thumper, Model: 1008Michigan Instruments, Inc. · 2008
  7. Descendant · cites it directly · 5 of its ownK090422 LUCAS 2Jolife AB · 2009 · Recalled
  8. Descendant · 2 generations on · 2 of its ownK161768 LUCAS 3 Chest Compression SystemJolife AB · 2016 · Recalled
  9. Descendant · 3 generations on · 1 of its ownK173553 LUCAS 3 Chest Compression SystemJolife AB · 2018
  10. Descendant · 4 generations on · 0 of its ownK211289 RMU-2000 Automated Chest Compression SystemDefibtech, LLC · 2021 · Recalled (Class I)
  11. Descendant · 2 generations on · 0 of its ownK153628 ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC · 2016

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

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

Class I recalls in this family

Most influential descendants

Showing 5 of 6 · 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
  • K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLC · 2021 · 4 generations on0descendants
  • K153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K851139Thumper Cardiopulmonary Resuscitator 1005Michigan Instruments, Inc.1985—
−4K022345Autopulse Resuscitation SystemRevivant Corp.20022
−3K032852Modification to: Autopulse Resuscitation System Model 100Revivant Corp.20032
−2K040453Autopulse Resuscitation System, Model 100Revivant Corp.20042
−1K063602Autopulse Resuscitation System MODEL100Zoll Circulation20061
0 (this device)K073079Thumper, Model: 1008Michigan Instruments, Inc.2008—
+1K090422LUCAS 2Jolife AB20093
+2K161768LUCAS 3 Chest Compression SystemJolife AB20162
+3K173553LUCAS 3 Chest Compression SystemJolife AB2018—
+4K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLC2021Class I
+2K153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201410
201620
201810
202111
FIG. 1 — Lineage of K073079, 1985–2021Source: 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), 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 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? (2)

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
*K972525Thumper
Summary page 1
…ion Name External Cardiac Compressor, Product Code DRM, Regulation Number 870.5200 Predicate Devices Thumper® Cardiopulmonary Resuscitator, Model 1007 (K972525) ZOLLO AutoPulse® (K063602) Purpose of the Special 510(k) Notice The Thumper®)Model 1008 is a modification to Thumper…
Michigan Instruments, Inc.19973
*K063602Autopulse Resuscitation System MODEL100
Summary page 1
…Compressor, Product Code DRM, Regulation Number 870.5200 Predicate Devices Thumper® Cardiopulmonary Resuscitator, Model 1007 (K972525) ZOLLO AutoPulse® (K063602) Purpose of the Special 510(k) Notice The Thumper®)Model 1008 is a modification to Thumper® Model 1007. In…
Zoll Circulation20061

Also cleared against K972525: 4 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K090422LUCAS 2Jolife AB20095

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.

  • 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?

  • The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • 6 of the 7 ancestors have a recall of any class.
  • Of its descendants, K090422 (Jolife AB, 2009) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K972525.

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—

What is it indicated for?

This device is used to perform Cardiopulmonary Resuscitation (CPR)

on adult patients and only adult patients in cases of clinical death as

defined by a lack of spontaneous breathing and pulse.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K073079: Thumper, Model: 1008.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073079

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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