Cleared Traditional

K073079 - THUMPER, MODEL: 1008

K073079 is an FDA 510(k) clearance for THUMPER, manufactured by Michigan Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DRM cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K073079 · Michigan Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
106d
Days
Class 2
Risk

K073079 is an FDA 510(k) clearance for the THUMPER, MODEL: 1008. Classified as Compressor, Cardiac, External (product code DRM), Class II - Special Controls.

Submitted by Michigan Instruments, Inc. (Washington, US). The FDA issued a Cleared decision on February 14, 2008 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Michigan Instruments, Inc. devices

FDA 510(k) Submission Details - K073079

510(k) Number K073079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2007
Decision Date February 14, 2008
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRM Device Classification - Class 2, Special Controls

Product Code DRM Compressor, Cardiac, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRM Compressor, Cardiac, External

All 12
Devices cleared under the same product code (DRM) and FDA review panel - the closest regulatory comparables to K073079.
AutoPulse NXT Resuscitation System
K221700 · Zoll Circulation, Inc. · Mar 2023
RMU-2000 Automated Chest Compression System
K211289 · Defibtech, LLC · Nov 2021
LUCAS 3 Chest Compression System
K173553 · Jolife AB · Feb 2018
THUMPER
K972525 · Michigan Instruments, Inc. · Oct 1997
HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.
K871271 · Huntleigh Technology, Inc. · Sep 1987
HUNTLEIGH FLOWPAC FP2000
K871272 · Huntleigh Technology, Inc. · Jun 1987