Cleared Traditional

K022233 - HYDROBOOT

K022233 is an FDA 510(k) clearance for HYDROBOOT, manufactured by Incappe, Inc.. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K022233 · Incappe, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
33d
Days
Class 2
Risk

K022233 is an FDA 510(k) clearance for the HYDROBOOT. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Incappe, Inc. (Wilmington, US). The FDA issued a Cleared decision on August 12, 2002 after a review of 33 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K022233

510(k) Number K022233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2002
Decision Date August 12, 2002
Days to Decision 33 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 129d · This submission: 33d
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 63
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K022233.
MEDI BUTLER
K051324 · Medi USA, LP · Dec 2005
FLIGHT SOCK
K040353 · Ssl Americas, Inc. · Mar 2004
JOBST TRAVEL SOCKS
K032325 · Bsn-Jobst, Inc. · Aug 2003
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
K020538 · Boehringer Laboratories · May 2002
DM SLEEVE
K021102 · Emily Iker M.D., A.P.C. · May 2002
ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001
K020592 · Alba-Waldensian, Inc. · Apr 2002
K022233 · HYDROBOOT
Download PDF FDA Summary Incappe, Inc.