Cleared Traditional

K880303 - POLYCORD II

K880303 is an FDA 510(k) clearance for POLYCORD II, manufactured by Technetics, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K880303 · Technetics, Inc. · Cardiovascular device
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Dec 1988
Decision
315d
Days
Class 2
Risk

K880303 is an FDA 510(k) clearance for the POLYCORD II. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Technetics, Inc. (El Cajon, US). The FDA issued a Cleared decision on December 5, 1988 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Technetics, Inc. devices

FDA 510(k) Submission Details - K880303

510(k) Number K880303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1988
Decision Date December 05, 1988
Days to Decision 315 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 125d · This submission: 315d
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 K880303.
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MODEL 463 ELECTROCARDIORECORDER RECORDER
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RHYTHMSCAN HR HOLTER RECORDER
K882366 · Brentwood Instruments, Inc. · Aug 1988
MODEL 492 SSR (TM) RECORDER
K874313 · Del Mar Avionics · Feb 1988