Cleared Traditional

K842497 - SERVOMED OXYMONITO SMK 363

K842497 is an FDA 510(k) clearance for SERVOMED OXYMONITO SMK 363, manufactured by Litton Datamedix. The device is a Class 2 Anesthesiology device with product code KLK cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K842497 · Litton Datamedix · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
100d
Days
Class 2
Risk

K842497 is an FDA 510(k) clearance for the SERVOMED OXYMONITO SMK 363. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Litton Datamedix (Mchenry, US). The FDA issued a Cleared decision on October 4, 1984 after a review of 100 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 Litton Datamedix devices

FDA 510(k) Submission Details - K842497

510(k) Number K842497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1984
Decision Date October 04, 1984
Days to Decision 100 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 140d · This submission: 100d
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 K842497.
KONTRON CUTANEOUS PO2 MONITOR 820
K860951 · Kontron Instruments, Inc. · Apr 1986
NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2
K844253 · Novametrix Medical Systems, Inc. · Jan 1985
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
MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT
K840918 · Biochem International, Inc. · Apr 1984