Cleared Traditional

K770341 - TEMP. PROBE

K770341 is the FDA 510(k) clearance for TEMP. PROBE by Electro-Catheter Corp.. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K770341 · Electro-Catheter Corp. · Cardiovascular device
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Feb 1977
Decision
10d
Days
Class 2
Risk

K770341 is an FDA 510(k) clearance for the TEMP. PROBE, & ELECTRONIC THERMOMETER. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Electro-Catheter Corp. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1977 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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.

View all Electro-Catheter Corp. devices

Submission Details

510(k) Number K770341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1977
Decision Date February 28, 1977
Days to Decision 10 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 125d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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.