Cleared Special

K161209 - Cirona 6400 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K161209 · Devon Medical Products · Cardiovascular device
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May 2016
Decision
33d
Days
Class 2
Risk

K161209 is an FDA 510(k) clearance for the Cirona 6400. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Devon Medical Products (King Of Prussia, US). The FDA issued a Cleared decision on May 31, 2016 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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 Devon Medical Products devices

Submission Details

510(k) Number K161209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2016
Decision Date May 31, 2016
Days to Decision 33 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
92d faster than avg
Panel avg: 125d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 - JOW Sleeve, Limb, Compressible

All 349
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K161209.
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