Cleared Abbreviated

K021509 - HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089

K021509 is an FDA 510(k) clearance for HYGIA HEALTH SERVICES REPROCESSED NOVAM..., manufactured by Hygia Health Services, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Abbreviated 510(k) pathway after a 229-day FDA review.

K021509 · Hygia Health Services, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
229d
Days
Class 2
Risk

K021509 is an FDA 510(k) clearance for the HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Hygia Health Services, Inc. (Birmingham, US). The FDA issued a Cleared decision on December 24, 2002 after a review of 229 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hygia Health Services, Inc. devices

FDA 510(k) Submission Details - K021509

510(k) Number K021509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2002
Decision Date December 24, 2002
Days to Decision 229 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 125d · This submission: 229d
Pathway characteristics
Standards-based clearance path.

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 324
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K021509.
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REPROCESSED COMPRESSION SLEEVE
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WIZAIR COMPRESSION SYSTEM
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