Cleared Traditional

K033646 - TRIFIT 700

K033646 is an FDA 510(k) clearance for TRIFIT 700, manufactured by Healthfirst Corp.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 467-day FDA review.

K033646 · Healthfirst Corp. · Cardiovascular device
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Mar 2005
Decision
467d
Days
Class 2
Risk

K033646 is an FDA 510(k) clearance for the TRIFIT 700. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Healthfirst Corp. (Albuquerque, US). The FDA issued a Cleared decision on March 1, 2005 after a review of 467 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 Healthfirst Corp. devices

FDA 510(k) Submission Details - K033646

510(k) Number K033646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2003
Decision Date March 01, 2005
Days to Decision 467 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
342d slower than avg
Panel avg: 125d · This submission: 467d
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 175
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