Cleared Traditional

K232516 - Sentec Digital Monitoring System (SDMS)...

K232516 is an FDA 510(k) clearance for Sentec Digital Monitoring System (SDMS)..., manufactured by Sentec AG. The device is a Class 2 Anesthesiology device with product code LKD cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K232516 · Sentec AG · Anesthesiology device
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May 2024
Decision
273d
Days
Class 2
Risk

K232516 is an FDA 510(k) clearance for the Sentec Digital Monitoring System (SDMS) tCOM+. Classified as Monitor, Carbon-dioxide, Cutaneous (product code LKD), Class II - Special Controls.

Submitted by Sentec AG (Therwil, CH). The FDA issued a Cleared decision on May 17, 2024 after a review of 273 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2480 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sentec AG devices

FDA 510(k) Submission Details - K232516

510(k) Number K232516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2023
Decision Date May 17, 2024
Days to Decision 273 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 140d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKD Device Classification - Class 2, Special Controls

Product Code LKD Monitor, Carbon-dioxide, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2480
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 Anesthesiology devices follow this clearance model.

Regulatory Consultant

ProMedic Consulting, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LKD Monitor, Carbon-dioxide, Cutaneous

All 8
Devices cleared under the same product code (LKD) and FDA review panel - the closest regulatory comparables to K232516.
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