Cleared Traditional

K950389 - SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR

K950389 is an FDA 510(k) clearance for SORBA MODEL CIC-1000 NON-INVASIVE HEMOD..., manufactured by Sorba Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K950389 · Sorba Medical Systems, Inc. · Cardiovascular device
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Aug 1995
Decision
195d
Days
Class 2
Risk

K950389 is an FDA 510(k) clearance for the SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Sorba Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on August 15, 1995 after a review of 195 days - an extended review cycle.

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: 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.

FDA 510(k) Submission Details - K950389

510(k) Number K950389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1995
Decision Date August 15, 1995
Days to Decision 195 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 125d · This submission: 195d
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 114
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K950389.
FUTREX-5000
K922600 · Futrex, Inc. · Dec 1995
FUTREX-5000A
K922601 · Futrex, Inc. · Dec 1995
BODYSTAY
K951097 · Bodystat , Ltd. · Nov 1995
HYPERGRAPH
K941162 · Dermed Diagnostics, Inc. · Dec 1994
BODY FAT ANALYZER MODEL TBF-105
K930599 · Tanita Corp. of America · Nov 1994
MODEL IPM-1 IMPEDANCE PULSE MONITOR
K932438 · Electro-Diagnostic Instruments · Dec 1993
K950389 · SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR
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