Cleared Special

K141609 - PULSTAR LOGIX PUMP

K141609 is an FDA 510(k) clearance for PULSTAR LOGIX PUMP, manufactured by Albahealth, LLC. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Special 510(k) pathway after a 29-day FDA review.

K141609 · Albahealth, LLC · Cardiovascular device
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Jul 2014
Decision
29d
Days
Class 2
Risk

K141609 is an FDA 510(k) clearance for the PULSTAR LOGIX PUMP. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Albahealth, LLC (Rockwood, US). The FDA issued a Cleared decision on July 15, 2014 after a review of 29 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 Albahealth, LLC devices

FDA 510(k) Submission Details - K141609

510(k) Number K141609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2014
Decision Date July 15, 2014
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

JOW Device Classification - Class 2, Special Controls

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 123
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