Cleared Traditional

K790757 - LIFEPAK 5 MONITOR

K790757 is an FDA 510(k) clearance for LIFEPAK 5 MONITOR, manufactured by Physio-Control Corp.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K790757 · Physio-Control Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1979
Decision
45d
Days
Class 2
Risk

K790757 is an FDA 510(k) clearance for the LIFEPAK 5 MONITOR, CASSETTE, #800923-01. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Physio-Control Corp. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1979 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Physio-Control Corp. devices

FDA 510(k) Submission Details - K790757

510(k) Number K790757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1979
Decision Date June 01, 1979
Days to Decision 45 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
80d faster than avg
Panel avg: 125d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 82
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K790757.
MODEL 448 PACERCORDER
K792076 · Del Mar Avionics · Dec 1979
MODEL 449 ELECTROCARDIOCORDER
K792078 · Del Mar Avionics · Dec 1979
MODEL 447 ELECTROCARDIOCORDER
K792079 · Del Mar Avionics · Dec 1979
RECORDER, MEDILOG II
K790286 · Oxford Medilog, Inc. · Feb 1979
PB-4 REPLAY UNIT
K790289 · Oxford Medilog, Inc. · Feb 1979
RECORDER, DINMAP, MODEL 950
K771932 · Applied Medical Research · Nov 1977