Cleared Traditional

K872048 - TRANSONIC FLOWMETER

K872048 is an FDA 510(k) clearance for TRANSONIC FLOWMETER, manufactured by Transonic Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 390-day FDA review.

K872048 · Transonic Systems, Inc. · Cardiovascular device
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Jun 1988
Decision
390d
Days
Class 2
Risk

K872048 is an FDA 510(k) clearance for the TRANSONIC FLOWMETER. 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 June 21, 1988 after a review of 390 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Transonic Systems, Inc. devices

FDA 510(k) Submission Details - K872048

510(k) Number K872048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1987
Decision Date June 21, 1988
Days to Decision 390 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 125d · This submission: 390d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

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 57
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K872048.
NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.
K894631 · Nihon Kohden America, Inc. · Jan 1990
IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER
K882138 · Imex Medical Systems, Inc. · Nov 1988
MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM
K882593 · Cardio Metrics, Inc. · Aug 1988
COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION
K871490 · Ge Medical Systems Information Technologies · Dec 1987
HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD
K872068 · Advanced Technology Laboratories, Inc. · Sep 1987
VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES
K862720 · Sonicaid, Inc. · Nov 1986