Cleared Traditional

K913013 - TCPO2 9260 MODULE - SYSTEM ATHENA

K913013 is an FDA 510(k) clearance for TCPO2 9260 MODULE - SYSTEM ATHENA, manufactured by S & W Medico Teknik. The device is a Class 2 Anesthesiology device with product code LKD cleared through the Traditional 510(k) pathway after a 1030-day FDA review.

K913013 · S & W Medico Teknik · Anesthesiology device
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May 1994
Decision
1030d
Days
Class 2
Risk

K913013 is an FDA 510(k) clearance for the TCPO2 9260 MODULE - SYSTEM ATHENA. Classified as Monitor, Carbon-dioxide, Cutaneous (product code LKD), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on May 3, 1994 after a review of 1030 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all S & W Medico Teknik devices

FDA 510(k) Submission Details - K913013

510(k) Number K913013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date May 03, 1994
Days to Decision 1030 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
890d slower than avg
Panel avg: 140d · This submission: 1030d
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 K913013.
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
K093154 · Radiometer Medical Aps · Feb 2010
TCM40 MONITORING SYSTEM
K043003 · Radiometer Medical Aps · Mar 2005
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
K980756 · Ge Medical Systems Information Technologies · Nov 1998
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
K900333 · Radiometer America, Inc. · Apr 1990
TRANSCUTANEOUS O2/CO2 MONITOR
K890517 · Novametrix Medical Systems, Inc. · Apr 1989
MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS
K883606 · Hewlett-Packard Co. · Dec 1988