Cleared Traditional

K770709 - PROBE

K770709 is the FDA 510(k) clearance for PROBE by 3M Health Care, Sarns. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K770709 · 3M Health Care, Sarns · Cardiovascular device
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Apr 1977
Decision
9d
Days
Class 2
Risk

K770709 is an FDA 510(k) clearance for the PROBE, TEMPERATURE, SYSTEM, SARNS. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Mchenry, US). The FDA issued a Cleared decision on April 27, 1977 after a review of 9 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 3M Health Care, Sarns devices

Submission Details

510(k) Number K770709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1977
Decision Date April 27, 1977
Days to Decision 9 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 125d · This submission: 9d
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.

Regulatory Peers - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 97
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K770709.
ELECATH GALLAGHER MAPPING CATHETER
K844805 · Electro-Catheter Corp. · Jan 1985
MODEL TP THERMISTOR PROBE
K831528 · Scimed Life Systems, Inc. · Jun 1983
MAPPING PROBE MODEL #6540
K802058 · Cardiac Pacemakers, Inc. · Nov 1980
CITADEL REFERENCE ELECTRODE
K770477 · Sherwood Medical Industries · Mar 1977
TEMP. PROBE, & ELECTRONIC THERMOMETER
K770341 · Electro-Catheter Corp. · Feb 1977