Cleared Traditional

K800214 - CIRCAMED I

K800214 is an FDA 510(k) clearance for CIRCAMED I, manufactured by Circadian, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K800214 · Circadian, Inc. · Cardiovascular device
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Feb 1980
Decision
28d
Days
Class 2
Risk

K800214 is an FDA 510(k) clearance for the CIRCAMED I. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Circadian, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 29, 1980 after a review of 28 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 Circadian, Inc. devices

FDA 510(k) Submission Details - K800214

510(k) Number K800214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1980
Decision Date February 29, 1980
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
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 121
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K800214.
ADVANCEMED HOLTER RECORDERS
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K801001 · Burdick Corp. · May 1980
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