Cleared Traditional

K903633 - ADVANCE LASER FLOWMETER

K903633 is the FDA 510(k) clearance for ADVANCE LASER FLOWMETER by Transonic Systems, Inc.. It is a Class 2 Cardiovascular device (product code DPW) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K903633 · Transonic Systems, Inc. · Cardiovascular device
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Oct 1990
Decision
60d
Days
Class 2
Risk

K903633 is an FDA 510(k) clearance for the ADVANCE LASER FLOWMETER, ALF 21. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on October 9, 1990 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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 Transonic Systems, Inc. devices

Submission Details

510(k) Number K903633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1990
Decision Date October 09, 1990
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 28
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