Cleared Traditional

K875179 - MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A

K875179 is an FDA 510(k) clearance for MODIFIED LASERFLO BLOOD PERFUSION MONITOR, manufactured by Tsi, Inc.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K875179 · Tsi, Inc. · Cardiovascular device
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Sep 1988
Decision
277d
Days
Class 2
Risk

K875179 is an FDA 510(k) clearance for the MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Tsi, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 19, 1988 after a review of 277 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Tsi, Inc. devices

FDA 510(k) Submission Details - K875179

510(k) Number K875179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1987
Decision Date September 19, 1988
Days to Decision 277 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 125d · This submission: 277d
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 81
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K875179.
FLAT VASCULAR PROBE
K896613 · Imex Medical Systems, Inc. · Feb 1990
NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.
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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