Cleared Traditional

K950688 - OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM

K950688 is an FDA 510(k) clearance for OMIN-TRAK MODEL 3500 SERIES PATIENT MON..., manufactured by Safety Tek Corp.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 429-day FDA review.

K950688 · Safety Tek Corp. · Cardiovascular device
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Apr 1996
Decision
429d
Days
Class 2
Risk

K950688 is an FDA 510(k) clearance for the OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Safety Tek Corp. (Orlando, US). The FDA issued a Cleared decision on April 18, 1996 after a review of 429 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Safety Tek Corp. devices

FDA 510(k) Submission Details - K950688

510(k) Number K950688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1995
Decision Date April 18, 1996
Days to Decision 429 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
304d slower than avg
Panel avg: 125d · This submission: 429d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 206
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K950688.
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MERCURY
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