Cleared Traditional

K873337 - MODEL SSR1 HOLTER MONITOR

K873337 is an FDA 510(k) clearance for MODEL SSR1 HOLTER MONITOR, manufactured by Cardiodata Corp.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K873337 · Cardiodata Corp. · Cardiovascular device
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Oct 1987
Decision
51d
Days
Class 2
Risk

K873337 is an FDA 510(k) clearance for the MODEL SSR1 HOLTER MONITOR. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Cardiodata Corp. (Northborough, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 51 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 Cardiodata Corp. devices

FDA 510(k) Submission Details - K873337

510(k) Number K873337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1987
Decision Date October 09, 1987
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
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 K873337.
MODEL 459 ELECTROCARDIOCORDER RECORDER
K884009 · Del Mar Avionics · Nov 1988
RHYTHMSCAN HR HOLTER RECORDER
K882366 · Brentwood Instruments, Inc. · Aug 1988
MODEL 492 SSR (TM) RECORDER
K874313 · Del Mar Avionics · Feb 1988
MODIFIED MODEL 9431 TELETRACE TRANSMITTER
K872246 · Medtronic Vascular · Jul 1987
NIGHTWATCH(TM) SYSTEM
K870578 · Buckman Co., Inc. · Jun 1987
MODEL 509A PHYSIOCORDER AMBULATORY RECORDER
K854269 · Del Mar Avionics · Apr 1986