Cleared Traditional

K101614 - HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809

K101614 is an FDA 510(k) clearance for HEELSAFE DVT HOSE, manufactured by Dm Systems, Incorporated. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K101614 · Dm Systems, Incorporated · General Hospital
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Jan 2011
Decision
218d
Days
Class 2
Risk

K101614 is an FDA 510(k) clearance for the HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Dm Systems, Incorporated (Folsm, US). The FDA issued a Cleared decision on January 13, 2011 after a review of 218 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5780 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K101614

510(k) Number K101614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2010
Decision Date January 13, 2011
Days to Decision 218 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 129d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWL Device Classification - Class 2, Special Controls

Product Code DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5780
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 General Hospital devices follow this clearance model.

Regulatory Peers - DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)

All 50
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K101614 · HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809
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