VenoTrain soft 21280025120232

by Bauerfeind GmbH & Co.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04057532463700 UDI-DI	Date1 Feb 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK860826	Date18 Jun 1986Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: VenoTrain soft
Generic name: Compression/pressure sock/stocking, single-use
Model / reference: 21280025120232

Primary DI / UDI-DI: 04057532463700
510(k) Number: K860826
FDA product code: DWL
GMDN term: Compression/pressure sock/stocking, single-use

Device class: Class II
Regulation number: 880.5780
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Over-the-counter
Lot / batch number
Expiration date

Other properties (11)

Supplied sterile: No
Sterilise before use: No
Implantable: No
Contains latex: No
Prescription use: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Manufacturing date: No