Cleared Traditional

K852959 - PO-510 TCPO2 MONITOR

K852959 is an FDA 510(k) clearance for PO-510 TCPO2 MONITOR, manufactured by Sumitomo Electric Industries, Inc.. The device is a Class 2 Anesthesiology device with product code KLK cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K852959 · Sumitomo Electric Industries, Inc. · Anesthesiology device
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Nov 1985
Decision
140d
Days
Class 2
Risk

K852959 is an FDA 510(k) clearance for the PO-510 TCPO2 MONITOR. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Sumitomo Electric Industries, Inc. (Osaka, 554 Japan, JP). The FDA issued a Cleared decision on November 29, 1985 after a review of 140 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 Sumitomo Electric Industries, Inc. devices

FDA 510(k) Submission Details - K852959

510(k) Number K852959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1985
Decision Date November 29, 1985
Days to Decision 140 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 140d · This submission: 140d
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 K852959.
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