Cleared Traditional

K772186 - ELECTROCARDIOGRAPH TRANSMITTER

K772186 is an FDA 510(k) clearance for ELECTROCARDIOGRAPH TRANSMITTER, manufactured by Intermedics, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K772186 · Intermedics, Inc. · Cardiovascular device
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Feb 1978
Decision
69d
Days
Class 2
Risk

K772186 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPH TRANSMITTER, 536. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Intermedics, Inc. (Walker, US). The FDA issued a Cleared decision on February 2, 1978 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K772186

510(k) Number K772186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1977
Decision Date February 02, 1978
Days to Decision 69 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
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 116
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K772186.
TRANSMITTER, MODEL 9406 AND 9401
K781986 · Medtronic Vascular · Dec 1978
TELETRACE TELEPHONE EKG TRANSMITTER
K780158 · Medtronic Vascular · Mar 1978
PATIENT ALERT MODEL 555
K772350 · Intermedics, Inc. · Mar 1978
TR-3 TRANSMITTER
K760857 · Burdick Corp. · Jan 1977
ECG MONITOR (TELEPHONE ECG TRANSMITTER)
K761066 · Physio-Control Corp. · Dec 1976
ECG MODULATOR
K760563 · Physio-Control Corp. · Sep 1976