Cleared Traditional

K830197 - TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS

K830197 is the FDA 510(k) clearance for TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS by Diamond Shamrock Corp.. It is a Class 2 Anesthesiology device (product code KLK) cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K830197 · Diamond Shamrock Corp. · Anesthesiology device
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Nov 1983
Decision
313d
Days
Class 2
Risk

K830197 is an FDA 510(k) clearance for the TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Diamond Shamrock Corp. (Walker, US). The FDA issued a Cleared decision on November 29, 1983 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Diamond Shamrock Corp. devices

Submission Details

510(k) Number K830197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1983
Decision Date November 29, 1983
Days to Decision 313 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 140d · This submission: 313d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (KLK) and FDA review panel - the closest regulatory comparables to K830197.
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
K925910 · Hewlett-Packard Co. · Jul 1993
515A NEO-TRAK NEONATAL MONITOR
K861861 · Ge Medical Systems Information Technologies · Jul 1986
IL 301 PORTABLE TRANSCUT. OXYGEN MONI
K834057 · Instrumentation Laboratory CO · Feb 1984
TRANSCUTANEOUS OXYGEN MONITOR OPTION
K831744 · Ge Medical Systems Information Technologies · Jul 1983
IL 301 TRANSCUTANEOUS OXYGEN MONITOR
K822328 · Instrumentation Laboratory CO · Sep 1982
MODEL 78850 OXYGEN MONITOR
K812167 · Hewlett-Packard Co. · Aug 1981