Cleared Traditional

K101690 - SENTEC DIGITAL MONITOR

K101690 is an FDA 510(k) clearance for SENTEC DIGITAL MONITOR, 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 170-day FDA review.

K101690 · Sentec AG · Anesthesiology device
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Dec 2010
Decision
170d
Days
Class 2
Risk

K101690 is an FDA 510(k) clearance for the SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR.... Classified as Monitor, Carbon-dioxide, Cutaneous (product code LKD), Class II - Special Controls.

Submitted by Sentec AG (Egale, US). The FDA issued a Cleared decision on December 3, 2010 after a review of 170 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 - K101690

510(k) Number K101690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2010
Decision Date December 03, 2010
Days to Decision 170 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 140d · This submission: 170d
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 Peers - LKD Monitor, Carbon-dioxide, Cutaneous

All 9
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