Cleared Traditional

K231104 - ABPMpro

K231104 is an FDA 510(k) clearance for ABPMpro, manufactured by Somnomedics GmbH. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 222-day FDA review.

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

FDA 510(k) Submission Details - K231104

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.

DSH Device Classification - Class 2, Special Controls

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 78
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K231104.
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