Cleared Traditional

K960614 - SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)

K960614 is an FDA 510(k) clearance for SOMANETICS INVOS 3100A CEREBRAL OXIMETE..., manufactured by Somanetics Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K960614 · Somanetics Corp. · Anesthesiology device
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Jun 1996
Decision
113d
Days
Class 2
Risk

K960614 is an FDA 510(k) clearance for the SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Somanetics Corp. (Troy, US). The FDA issued a Cleared decision on June 5, 1996 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Somanetics Corp. devices

FDA 510(k) Submission Details - K960614

510(k) Number K960614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1996
Decision Date June 05, 1996
Days to Decision 113 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
27d faster than avg
Panel avg: 140d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 511
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K960614.
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OXILINK (SMALL, MEDIUM, LARGE)
K953126 · Bci Intl., Inc. · Sep 1995