Cleared Traditional

K980756 - COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE

K980756 is an FDA 510(k) clearance for COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Anesthesiology device with product code LKD cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K980756 · Ge Medical Systems Information Technologies · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
251d
Days
Class 2
Risk

K980756 is an FDA 510(k) clearance for the COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE. Classified as Monitor, Carbon-dioxide, Cutaneous (product code LKD), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on November 5, 1998 after a review of 251 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2480 - 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K980756

510(k) Number K980756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1998
Decision Date November 05, 1998
Days to Decision 251 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 140d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKD Device Classification - Class 2, Special Controls

Product Code LKD Monitor, Carbon-dioxide, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2480
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 - LKD Monitor, Carbon-dioxide, Cutaneous

All 8
Devices cleared under the same product code (LKD) and FDA review panel - the closest regulatory comparables to K980756.
PHILIPS INTELLIVUE TCG10
K110474 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Sep 2011
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
K093154 · Radiometer Medical Aps · Feb 2010
TCM40 MONITORING SYSTEM
K043003 · Radiometer Medical Aps · Mar 2005
TCPO2 9260 MODULE - SYSTEM ATHENA
K913013 · S & W Medico Teknik · May 1994
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
K900333 · Radiometer America, Inc. · Apr 1990
TRANSCUTANEOUS O2/CO2 MONITOR
K890517 · Novametrix Medical Systems, Inc. · Apr 1989