Cleared Traditional

K840918 - MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT

K840918 is an FDA 510(k) clearance for MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT, 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 47-day FDA review.

K840918 · Biochem International, Inc. · Anesthesiology device
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Apr 1984
Decision
47d
Days
Class 2
Risk

K840918 is an FDA 510(k) clearance for the MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Biochem International, Inc. (Walker, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 47 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 - K840918

510(k) Number K840918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1984
Decision Date April 17, 1984
Days to Decision 47 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
93d faster than avg
Panel avg: 140d · This submission: 47d
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 K840918.
NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN
K844079 · Novametrix Medical Systems, Inc. · Nov 1984
NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN
K842374 · Novametrix Medical Systems, Inc. · Sep 1984
TRANSCUTANEOUS 800-OXYGEN MONITORS/801
K840993 · Novametrix Medical Systems, Inc. · Apr 1984
PATIENT MONITOR #404
K831319 · Analogic Corp. · Mar 1984
IL 301 PORTABLE TRANSCUT. OXYGEN MONI
K834057 · Instrumentation Laboratory CO · Feb 1984
OXY MONITOR 5-RANGE DUAL-THERMISTOR
K832652 · Litton Medical Electronics · Dec 1983