Cleared Traditional

K830197 - TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS

K830197 is an FDA 510(k) clearance for TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS, manufactured by Diamond Shamrock Corp.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K830197

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.

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 K830197.
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
TRANSCUTANEOUS OXYGEN MONITOR OPTION
K831744 · Ge Medical Systems Information Technologies · Jul 1983
AS 30/TCP MODULE
K831460 · Narco Scientific · Jul 1983
IL 301 TRANSCUTANEOUS OXYGEN MONITOR
K822328 · Instrumentation Laboratory CO · Sep 1982