Cleared Traditional

K131860 - VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING

K131860 is an FDA 510(k) clearance for VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WIT..., manufactured by Us Vascular, LLC. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K131860 · Us Vascular, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
95d
Days
Class 2
Risk

K131860 is an FDA 510(k) clearance for the VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Us Vascular, LLC (Crofton, US). The FDA issued a Cleared decision on September 27, 2013 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - 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 Us Vascular, LLC devices

FDA 510(k) Submission Details - K131860

510(k) Number K131860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2013
Decision Date September 27, 2013
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 - JOP Transducer, Ultrasonic

All 48
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K131860.
VasoGuard (V10, V8, V6, V4, V2)
K233976 · Corvascular Diagnostics, LLC · Jul 2024
Smartdop XT6
K153762 · Koven Technology, Inc. · May 2016
SMARTDOP XT
K131623 · Koven Technology, Inc. · Jan 2014
REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8
K934638 · Koven Technology, Inc. · May 1994
UST-2266U-5 CW DOPPLER TRANSDUCER
K905369 · Ge Medical Systems Information Technologies · Feb 1991
MILLAR MIKRO-TIP DOPPLER CATHETER
K896264 · Millar Instruments, Inc. · Jan 1990