Cleared Traditional

K961368 - TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT

K961368 is an FDA 510(k) clearance for TRIMFLO PARENCHYMAL BLOOD FLOW MONITORI..., 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 185-day FDA review.

K961368 · Vasamedics, LLC · Cardiovascular device
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Oct 1996
Decision
185d
Days
Class 2
Risk

K961368 is an FDA 510(k) clearance for the TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT. 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 October 11, 1996 after a review of 185 days - an extended review cycle.

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. 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 Vasamedics, LLC devices

FDA 510(k) Submission Details - K961368

510(k) Number K961368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 09, 1996
Decision Date October 11, 1996
Days to Decision 185 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
60d slower than avg
Panel avg: 125d · This submission: 185d
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 K961368.
MOOORLDI LASER DOPPLER IMAGER
K980383 · Moor Instruments, Ltd. · Apr 1998
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
LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433
K951832 · Vasamedics, LLC · Mar 1996
TRANSTAR PRESSURE TRANSDUCER
K942377 · Medex, Inc. · Aug 1994
TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY
K912404 · Hewlett-Packard Co. · Nov 1991