Cleared Traditional

K951832 - LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433

K951832 is an FDA 510(k) clearance for LASERFLO BLOOD PERFUSION SINGLE USE PRO..., manufactured by Vasamedics, LLC. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K951832 · Vasamedics, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
336d
Days
Class 2
Risk

K951832 is an FDA 510(k) clearance for the LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Vasamedics, LLC (Saint Paul, US). The FDA issued a Cleared decision on March 21, 1996 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - 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 Vasamedics, LLC devices

FDA 510(k) Submission Details - K951832

510(k) Number K951832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1995
Decision Date March 21, 1996
Days to Decision 336 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 125d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPT Device Classification - Class 2, Special Controls

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
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 - DPT Probe, Blood-flow, Extravascular

All 28
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K951832.
ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
K963703 · International Biophysics Corp. · Apr 1998
VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT
K962700 · Vasamedics, LLC · Apr 1997
TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT
K961368 · Vasamedics, LLC · Oct 1996
TRANSTAR PRESSURE TRANSDUCER
K942377 · Medex, Inc. · Aug 1994
TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY
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SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
K905728 · Hewlett-Packard Co. · Mar 1991