Cleared Traditional

K790476 - QUICKSCAN HOLTER II

K790476 is an FDA 510(k) clearance for QUICKSCAN HOLTER II, manufactured by Intl. Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K790476 · Intl. Medical, Inc. · Cardiovascular device
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Jun 1979
Decision
88d
Days
Class 2
Risk

K790476 is an FDA 510(k) clearance for the QUICKSCAN HOLTER II. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Intl. Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1979 after a review of 88 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 Intl. Medical, Inc. devices

FDA 510(k) Submission Details - K790476

510(k) Number K790476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1979
Decision Date June 01, 1979
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 94
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K790476.
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
LIFEPAK 5 MONITOR, CASSETTE, #800923-01
K790757 · Physio-Control Corp. · Jun 1979
RECORDER, MEDILOG II
K790286 · Oxford Medilog, Inc. · Feb 1979
PB-4 REPLAY UNIT
K790289 · Oxford Medilog, Inc. · Feb 1979