Cleared Traditional

K863803 - VASOPULSE(TM)/MODEL 5000

K863803 is an FDA 510(k) clearance for VASOPULSE(TM)/MODEL 5000, manufactured by Sonicaid, Inc.. The device is a Class 2 Cardiovascular device with product code JOM cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K863803 · Sonicaid, Inc. · Cardiovascular device
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May 1987
Decision
219d
Days
Class 2
Risk

K863803 is an FDA 510(k) clearance for the VASOPULSE(TM)/MODEL 5000. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Sonicaid, Inc. (Fredericksburg, US). The FDA issued a Cleared decision on May 6, 1987 after a review of 219 days - an extended review 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: 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 Sonicaid, Inc. devices

FDA 510(k) Submission Details - K863803

510(k) Number K863803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1986
Decision Date May 06, 1987
Days to Decision 219 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
94d slower than avg
Panel avg: 125d · This submission: 219d
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 19
Devices cleared under the same product code (JOM) and FDA review panel - the closest regulatory comparables to K863803.
3D VASCULAR RECORDER
K883908 · D. E. Hokanson, Inc. · Oct 1988
TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM
K872517 · D. E. Hokanson, Inc. · Oct 1987
PULSE CUFF RECORDER MODEL PCR100
K863702 · Imex Medical Systems, Inc. · Jun 1987
OSM-1 OXYGEN SATURATION MONITOR
K853331 · Criticare Systems, Inc. · Jan 1986
NOVAMETRIX PULSE OXIMETER, MODEL 500
K853124 · Novametrix Medical Systems, Inc. · Nov 1985
PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH
K832374 · Sonicaid, Inc. · Dec 1983