Cleared Special

K014299 - SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH

K014299 is an FDA 510(k) clearance for SORBA STEORRA NON-INVASIVE IMPEDANCE CA..., manufactured by Sorba Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Special 510(k) pathway after a 30-day FDA review.

K014299 · Sorba Medical Systems, Inc. · Cardiovascular device
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Jan 2002
Decision
30d
Days
Class 2
Risk

K014299 is an FDA 510(k) clearance for the SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Sorba Medical Systems, Inc. (Brookfield, US). The FDA issued a Cleared decision on January 30, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sorba Medical Systems, Inc. devices

FDA 510(k) Submission Details - K014299

510(k) Number K014299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2001
Decision Date January 30, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 41
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