Cleared Traditional

K962783 - EDEMA SYSTEM

K962783 is an FDA 510(k) clearance for EDEMA SYSTEM, manufactured by Bioanalogics, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 463-day FDA review.

K962783 · Bioanalogics, Inc. · Cardiovascular device
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Oct 1997
Decision
463d
Days
Class 2
Risk

K962783 is an FDA 510(k) clearance for the EDEMA SYSTEM. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Bioanalogics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 23, 1997 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Bioanalogics, Inc. devices

FDA 510(k) Submission Details - K962783

510(k) Number K962783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1996
Decision Date October 23, 1997
Days to Decision 463 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
338d slower than avg
Panel avg: 125d · This submission: 463d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 - DSB Plethysmograph, Impedance

All 43
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K962783.
IQ SYSTEM
K981720 · Renaissance Technology, Inc. · Feb 1999
BIOZ.COM SYSTEM
K974725 · Cardiodynamics International Corp. · Mar 1998
PERCUPUMP II WITH EDA
K974621 · E-Z-Em, Inc. · Jan 1998
BIOZ SYSTEM & BIOZ PORTABLE
K972320 · Cardiodynamics International Corp. · Sep 1997
HOTMAN
K952172 · Hemo Sapiens, Inc. · Jun 1997
D SERIES ELECTRODE
K970603 · Cmc Sense-It, Inc. · Apr 1997