Cleared Traditional

PATIENT ALERT MODEL 555 (K772350) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K772350 · Intermedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1978
Decision
76d
Days
Class 2
Risk

K772350 is an FDA 510(k) clearance for the PATIENT ALERT MODEL 555. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1978 after a review of 76 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

Submission Details

510(k) Number K772350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1977
Decision Date March 09, 1978
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 53
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K772350.
MEDTRONIC MODEL 9410 TELETRACE RECEIVER
K791778 · Medtronic Vascular · Oct 1979
TRANSMITTER, MODEL 9406 AND 9401
K781986 · Medtronic Vascular · Dec 1978
TELETRACE TELEPHONE EKG TRANSMITTER
K780158 · Medtronic Vascular · Mar 1978
ELECTROCARDIOGRAPH TRANSMITTER, 536
K772186 · Intermedics, Inc. · Feb 1978