Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: DWL FDA class 2

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

General Hospital

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The Medical Support Stocking is a non-invasive device worn on the legs to apply graduated compression, preventing the pooling of venous blood in the lower extremities and reducing the risk of deep vein thrombosis, edema, or venous insufficiency. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWL and it is regulated under 21 CFR 880.5780 within the General Hospital medical specialty.

510(k) Clearances

50+ matches
K Number
Device Name
MEDLINE ANTI-EMBOLISM STOCKING
BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
ENCIRCLE COMPRESSION THERAPY STOCKING
BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS
FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE
ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
DR. SCHOLL'S COMPRESSION SOCKS
TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET
CURAD COMPRESSION HOSIERY
VENOTRAIN CURAFLOW
HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809
SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS
SHAPE TO FIT COMPRESSION WEAR
1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS
SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS
TORBOT VASCULAR COMPRESSION GARMENTS
MEDI BUTLER
FLIGHT SOCK
JOBST TRAVEL SOCKS
HYDROBOOT
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
DM SLEEVE
ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001
JOBST READY-TO-WEAR GAUNTLET
D. R. MEDICAL CONTROLLED PRESSURE GARMENTS
JOBST READY-TO-WEAR ARM SLEEVES
GEEN MEDISOX
OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS
ELVAREX
CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING
CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING
ANTI-EM/GP STOCKINGS
MARLENE STOCKINGS & TIGHTS
MEDICAL SUPPORT STOCKINGS
MEDICAL SUPPORT STOCKINGS 2001/2002
MEDI STRUMPF
JOBST-CUSTOM
RX FIT MEDICAL STOCKINGS
KENDALL HOME RX THERAPEUTIC STOCKING
ULTIMATE
JUZO-RESPIRA ANTI-EMBOLISM STOCKING
COMPRINET, COMTESSE AND BELLAVAR STOCKINGS
SCD THERAPEUTIC STOCKING SYSTEM
COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE
ULCERCARE
WRIGHT GRADIENT PRESSURE SUPPORT STOCKINGS
ULTRACARE
ENHANCE SUPPORT HOSE

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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