Cleared Traditional

K851057 - LASERFLO BLOOD PERFUSION MONITOR 403

K851057 is the FDA 510(k) clearance for LASERFLO BLOOD PERFUSION MONITOR 403 by Tsi, Inc.. It is a Class 2 Cardiovascular device (product code DPW) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K851057 · Tsi, Inc. · Cardiovascular device
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Jun 1985
Decision
102d
Days
Class 2
Risk

K851057 is an FDA 510(k) clearance for the LASERFLO BLOOD PERFUSION MONITOR 403. 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 June 24, 1985 after a review of 102 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K851057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1985
Decision Date June 24, 1985
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 125d · This submission: 102d
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 34
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K851057.
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