Cleared Traditional

K042388 - RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE

K042388 is an FDA 510(k) clearance for RADIANT MEDICAL ENDOCATHETER TEMPERATUR..., manufactured by Radiant Medical. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K042388 · Radiant Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
56d
Days
Class 2
Risk

K042388 is an FDA 510(k) clearance for the RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Radiant Medical (Redwood City, US). The FDA issued a Cleared decision on October 28, 2004 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042388

510(k) Number K042388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2004
Decision Date October 28, 2004
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 893
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K042388.
SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX
K042537 · Invatec Innovative Technologies · Nov 2004
SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX
K042538 · Invatec Innovative Technologies · Nov 2004
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
K042230 · Cryo Vascular Systems, Inc. · Nov 2004
EXCELSIOR 1018 AND SL-10 MICROCATHETERS
K042568 · Boston Scientific Corp · Oct 2004
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K042541 · Cryo Vascular Systems, Inc. · Oct 2004
ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY
K042194 · Medtronic Vascular · Sep 2004
K042388 · RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE
Download PDF FDA Summary Radiant Medical