Cleared Traditional

K973659 - VASOCOR PVR 100

K973659 is an FDA 510(k) clearance for VASOCOR PVR 100, manufactured by Vasocor, Inc.. The device is a Class 2 Cardiovascular device with product code JOM cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K973659 · Vasocor, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
83d
Days
Class 2
Risk

K973659 is an FDA 510(k) clearance for the VASOCOR PVR 100. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Vasocor, Inc. (Miami, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2780 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vasocor, Inc. devices

FDA 510(k) Submission Details - K973659

510(k) Number K973659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1997
Decision Date December 17, 1997
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOM Device Classification - Class 2, Special Controls

Product Code JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2780
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 - JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

All 30
Devices cleared under the same product code (JOM) and FDA review panel - the closest regulatory comparables to K973659.
PVR-100/VASOGRAM
K990123 · Vasocor, Inc. · Apr 1999
VENOMETER
K983900 · Advanced Medical Technology , Ltd. · Jan 1999
EC6 PLETHYSMOGRAPH
K982707 · D. E. Hokanson, Inc. · Aug 1998
DOPCORD PPG
K884451 · Huntleigh Technology, Inc. · Jan 1989
3D VASCULAR RECORDER
K883908 · D. E. Hokanson, Inc. · Oct 1988
TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM
K872517 · D. E. Hokanson, Inc. · Oct 1987