Cleared Traditional

K211289 - RMU-2000 Automated Chest Compression System

K211289 is an FDA 510(k) clearance for RMU-2000 Automated Chest Compression System, manufactured by Defibtech, LLC. The device is a Class 2 Cardiovascular device with product code DRM cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K211289 · Defibtech, LLC · Cardiovascular device
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Nov 2021
Decision
195d
Days
Class 2
Risk

K211289 is an FDA 510(k) clearance for the RMU-2000 Automated Chest Compression System. Classified as Compressor, Cardiac, External (product code DRM), Class II - Special Controls.

Submitted by Defibtech, LLC (Guilford, US). The FDA issued a Cleared decision on November 9, 2021 after a review of 195 days - an extended review cycle.

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 Defibtech, LLC devices

FDA 510(k) Submission Details - K211289

510(k) Number K211289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2021
Decision Date November 09, 2021
Days to Decision 195 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 125d · This submission: 195d
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.