Cleared Traditional

K832374 - PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH

K832374 is an FDA 510(k) clearance for PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH, 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 136-day FDA review.

K832374 · Sonicaid, Inc. · Cardiovascular device
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Dec 1983
Decision
136d
Days
Class 2
Risk

K832374 is an FDA 510(k) clearance for the PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Sonicaid, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 1, 1983 after a review of 136 days - within the typical 510(k) review window.

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 - K832374

510(k) Number K832374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1983
Decision Date December 01, 1983
Days to Decision 136 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
11d slower than avg
Panel avg: 125d · This submission: 136d
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 K832374.
VASOPULSE(TM)/MODEL 5000
K863803 · Sonicaid, Inc. · May 1987
OSM-1 OXYGEN SATURATION MONITOR
K853331 · Criticare Systems, Inc. · Jan 1986
NOVAMETRIX PULSE OXIMETER, MODEL 500
K853124 · Novametrix Medical Systems, Inc. · Nov 1985
HR 100T
K831955 · Thought Technology , Ltd. · Aug 1983
VASCULAB #VSC21
K812609 · Medasonics, Inc. · Oct 1981
EC-4 PLETHYSMOGRAPH
K801291 · D. E. Hokanson, Inc. · Jul 1980