Cleared Traditional

K781910 - MONITOR, SENSOMATIII OXYGEN

K781910 is an FDA 510(k) clearance for MONITOR, manufactured by Biochem International, Inc.. The device is a Class 2 Anesthesiology device with product code KLK cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K781910 · Biochem International, Inc. · Anesthesiology device
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Dec 1978
Decision
42d
Days
Class 2
Risk

K781910 is an FDA 510(k) clearance for the MONITOR, SENSOMATIII OXYGEN. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Biochem International, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 26, 1978 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biochem International, Inc. devices

FDA 510(k) Submission Details - K781910

510(k) Number K781910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1978
Decision Date December 26, 1978
Days to Decision 42 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 140d · This submission: 42d
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 33
Devices cleared under the same product code (KLK) and FDA review panel - the closest regulatory comparables to K781910.
TC02 M OXYGEN ELECTRODE CONTACT
K792009 · Novametrix Medical Systems, Inc. · Oct 1979
TC02M ELECTRODE ADHESIVE RINGS
K792010 · Novametrix Medical Systems, Inc. · Oct 1979
TCO2M MODEL 818
K791152 · Novametrix Medical Systems, Inc. · Aug 1979
TRANSCUTANEOUS OXYGEN PERFUSION MONITOR
K780458 · Narco Air-Shields · Oct 1978