Cleared Traditional

K231104 - ABPMpro (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231104 · Somnomedics GmbH · Cardiovascular device
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Nov 2023
Decision
222d
Days
Class 2
Risk

K231104 is an FDA 510(k) clearance for the ABPMpro. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Somnomedics GmbH (Randersacker, DE). The FDA issued a Cleared decision on November 27, 2023 after a review of 222 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Somnomedics GmbH devices

Submission Details

510(k) Number K231104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2023
Decision Date November 27, 2023
Days to Decision 222 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
97d slower than avg
Panel avg: 125d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 193
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