Cleared Traditional

K791559 - ROCHE SENSOR ADAPTOR

K791559 is an FDA 510(k) clearance for ROCHE SENSOR ADAPTOR, manufactured by Roche Medical Electronics, Inc.. The device is a Class 2 Anesthesiology device with product code KLK cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K791559 · Roche Medical Electronics, Inc. · Anesthesiology device
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Nov 1979
Decision
96d
Days
Class 2
Risk

K791559 is an FDA 510(k) clearance for the ROCHE SENSOR ADAPTOR. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Roche Medical Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 21, 1979 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2500 - 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 Roche Medical Electronics, Inc. devices

FDA 510(k) Submission Details - K791559

510(k) Number K791559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1979
Decision Date November 21, 1979
Days to Decision 96 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 140d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLK Device Classification - Class 2, Special Controls

Product Code KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2500
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 - KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

All 35
Devices cleared under the same product code (KLK) and FDA review panel - the closest regulatory comparables to K791559.
CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS
K810999 · Cordis Corp. · Jun 1981
LIFESPAN 100
K811470 · Biochem International, Inc. · Jun 1981
NOVAMETRIX TCOMETTE #809 TRANS. MONITOR
K800988 · Novametrix Medical Systems, Inc. · May 1980
TC02M PRECISION GAS CALIBRATOR
K792011 · Novametrix Medical Systems, Inc. · Nov 1979
TC02 M OXYGEN ELECTRODE CONTACT
K792009 · Novametrix Medical Systems, Inc. · Oct 1979
TC02M ELECTRODE ADHESIVE RINGS
K792010 · Novametrix Medical Systems, Inc. · Oct 1979