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Bionix Development Corporation Sp-20912

by Bionix, LLC

Bionix Development Corporation Sp-20912 is an enteral feeding tube clearing kit (FDA Class II; FDA product code KNT, Tubes, Gastrointestinal (and Accessories)) made by Bionix, LLC, cleared under FDA 510(k) K905164 on 13 Feb 1991 and listed in FDA GUDID since 22 Feb 2017 (UDI-DI 00859911004313), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K905164

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00859911004313 UDI-DI Date22 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK905164 Date13 Feb 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K905164 decided 13 Feb 1991 Active
  • FDA GUDID UDI-DI 00859911004313 listed 22 Feb 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K905164
  2. Listed FDA GUDID 00859911004313

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bionix Development Corporation
Generic name
Enteral feeding tube clearing kit
Model / Ref / Catalog
SP-20912, 20912
Primary DI / UDI-DI
00859911004313
510(k) Number
FDA product code
KNT
GMDN term
Enteral feeding tube clearing kit
Device class
Class II
Regulation number
876.5980
GUDID distribution status
In Commercial Distribution

Related devices

Category: Enteral feeding tube clearing kit

Cleared under the same submission (K905164)

and 5 more cleared under K905164

Similar devices

Other devices filed under FDA product code KNT (TUBES, GASTROINTESTINAL (AND ACCESSORIES)).

Other devices from Bionix, LLC

See all devices from Bionix, LLC →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)