Cleared Traditional

K123308 - PULSTAR LOGIX INTERMITTENT PNEUMATIC CO...

K123308 is an FDA 510(k) clearance for PULSTAR LOGIX INTERMITTENT PNEUMATIC CO..., manufactured by Albahealth, LLC. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K123308 · Albahealth, LLC · Cardiovascular device
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Feb 2013
Decision
107d
Days
Class 2
Risk

K123308 is an FDA 510(k) clearance for the PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM. 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 February 8, 2013 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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.

View all Albahealth, LLC devices

FDA 510(k) Submission Details - K123308

510(k) Number K123308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2012
Decision Date February 08, 2013
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 124
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K123308.
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