Cleared Traditional

K905225 - HBO CABLE ASSEMBLY, RADIOMETER TC-02

K905225 is an FDA 510(k) clearance for HBO CABLE ASSEMBLY, manufactured by Sechrist. The device is a Class 2 Radiology device with product code LKD cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K905225 · Sechrist · Radiology device
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Apr 1991
Decision
141d
Days
Class 2
Risk

K905225 is an FDA 510(k) clearance for the HBO CABLE ASSEMBLY, RADIOMETER TC-02. Classified as Monitor, Carbon-dioxide, Cutaneous (product code LKD), Class II - Special Controls.

Submitted by Sechrist (Anaheim, US). The FDA issued a Cleared decision on April 10, 1991 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 868.2480 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sechrist devices

FDA 510(k) Submission Details - K905225

510(k) Number K905225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date April 10, 1991
Days to Decision 141 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 107d · This submission: 141d
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 Radiology devices follow this clearance model.

Regulatory Peers - LKD Monitor, Carbon-dioxide, Cutaneous

All 15
Devices cleared under the same product code (LKD) and FDA review panel - the closest regulatory comparables to K905225.
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
K990960 · Perimed, Inc. · Sep 1999
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
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