Cleared Traditional

K012654 - HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40

K012654 is an FDA 510(k) clearance for HYGIA HEALTH SERVICES REPROCESSED HUNTL..., manufactured by Hygia Health Services, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K012654 · Hygia Health Services, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
242d
Days
Class 2
Risk

K012654 is an FDA 510(k) clearance for the HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10,.... 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 April 12, 2002 after a review of 242 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 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 Hygia Health Services, Inc. devices

FDA 510(k) Submission Details - K012654

510(k) Number K012654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date April 12, 2002
Days to Decision 242 days
Submission Type Traditional
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
117d slower than avg
Panel avg: 125d · This submission: 242d
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 324
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K012654.
KENDALL, SEQUENTIAL COMPRESSION DEVICE
K012614 · Medical Instruments Technology, Inc. · May 2002
HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP
K012650 · Hygia Health Services, Inc. · Apr 2002
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
K012651 · Hygia Health Services, Inc. · Apr 2002
HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP
K012657 · Hygia Health Services, Inc. · Apr 2002
HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB
K012956 · Hygia Health Services, Inc. · Apr 2002
HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480
K012417 · Hygia Health Services, Inc. · Apr 2002