Cleared Traditional

K902497 - SCD THERAPEUTIC STOCKING SYSTEM

K902497 is an FDA 510(k) clearance for SCD THERAPEUTIC STOCKING SYSTEM, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K902497 · Kendall Healthcare Products Co. Div.Of Tyco Health · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
71d
Days
Class 2
Risk

K902497 is an FDA 510(k) clearance for the SCD THERAPEUTIC STOCKING SYSTEM. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on August 15, 1990 after a review of 71 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.

View all Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K902497

510(k) Number K902497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1990
Decision Date August 15, 1990
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
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 8
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K902497.
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
K090921 · Beiersdorf, Inc. · Dec 2009
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
K020538 · Boehringer Laboratories · May 2002
KENDALL HOME RX THERAPEUTIC STOCKING
K925417 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jun 1993
ENHANCE SUPPORT HOSE
K873280 · Kimberly-Clark Corp. · Oct 1987
A.V.R. KNEE LENGTH THERAPEUTIC STOCK-
K832609 · The Kendal Co. · Sep 1983