Cleared Traditional

K900333 - E5280 COMBINED TRANSCUTANEOUS TCP02/TCP...

K900333 is an FDA 510(k) clearance for E5280 COMBINED TRANSCUTANEOUS TCP02/TCP..., manufactured by Radiometer America, Inc.. The device is a Class 2 Anesthesiology device with product code LKD cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K900333 · Radiometer America, Inc. · Anesthesiology device
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Apr 1990
Decision
83d
Days
Class 2
Risk

K900333 is an FDA 510(k) clearance for the E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.. Classified as Monitor, Carbon-dioxide, Cutaneous (product code LKD), Class II - Special Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on April 16, 1990 after a review of 83 days - a notably fast clearance 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: 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 Radiometer America, Inc. devices

FDA 510(k) Submission Details - K900333

510(k) Number K900333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1990
Decision Date April 16, 1990
Days to Decision 83 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
57d faster than avg
Panel avg: 140d · This submission: 83d
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 K900333.
TCM40 MONITORING SYSTEM
K043003 · Radiometer Medical Aps · Mar 2005
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
K980756 · Ge Medical Systems Information Technologies · Nov 1998
TCPO2 9260 MODULE - SYSTEM ATHENA
K913013 · S & W Medico Teknik · May 1994
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