Cleared Traditional

K810999 - CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS

K810999 is an FDA 510(k) clearance for CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS, manufactured by Cordis Corp.. The device is a Class 2 Anesthesiology device with product code KLK cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K810999 · Cordis Corp. · Anesthesiology device
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Jun 1981
Decision
72d
Days
Class 2
Risk

K810999 is an FDA 510(k) clearance for the CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1981 after a review of 72 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 Cordis Corp. devices

FDA 510(k) Submission Details - K810999

510(k) Number K810999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1981
Decision Date June 24, 1981
Days to Decision 72 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
68d faster than avg
Panel avg: 140d · This submission: 72d
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 32
Devices cleared under the same product code (KLK) and FDA review panel - the closest regulatory comparables to K810999.
NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN
K813352 · Novametrix Medical Systems, Inc. · Jan 1982
NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER
K813351 · Novametrix Medical Systems, Inc. · Dec 1981
MODEL 78850 OXYGEN MONITOR
K812167 · Hewlett-Packard Co. · Aug 1981
LIFESPAN 100
K811470 · Biochem International, Inc. · Jun 1981
NOVAMETRIX TCOMETTE #809 TRANS. MONITOR
K800988 · Novametrix Medical Systems, Inc. · May 1980
TC02M PRECISION GAS CALIBRATOR
K792011 · Novametrix Medical Systems, Inc. · Nov 1979