Cleared Traditional

K860121 - INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER

K860121 is an FDA 510(k) clearance for INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER, manufactured by NuMED, Inc.. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K860121 · NuMED, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
140d
Days
Class 2
Risk

K860121 is an FDA 510(k) clearance for the INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on June 2, 1986 after a review of 140 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K860121

510(k) Number K860121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1986
Decision Date June 02, 1986
Days to Decision 140 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 125d · This submission: 140d
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 47
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K860121.
PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM
K871912 · Electro-Diagnostic Instruments · Feb 1988
A-V RECORDER
K873041 · Life Sciences Manufacturing, Inc. · Feb 1988
SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES
K863372 · Interspec, Inc. · Nov 1986
MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER
K860435 · Multigon Industries, Inc. · May 1986
BIO-PROBE SYSTEM-BLOOD FLOW PROBE
K830858 · Bio Medicus, Inc. · Jun 1983
P-2 ULTRASONIC ARTERIOGRAPH
K792015 · D. E. Hokanson, Inc. · Dec 1979
K860121 · INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER
Download PDF NuMED, Inc.