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TubeClear NE-1048

by Actuated Medical, Inc.

TubeClear NE-1048 is a Class II device made by Actuated Medical, Inc., cleared under FDA 510(k) K172556 on 29 Jun 2018 (1 earlier submission) and listed in FDA GUDID since 27 Oct 2016 (UDI-DI 00850458007485), 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

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172556 Date29 Jun 2018DecidedStatusActive
United StatesGUDID listing Number00850458007485 UDI-DI Date27 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172556 decided 29 Jun 2018 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00850458007485 listed 27 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131052
  2. Listed FDA GUDID 00850458007485
  3. Cleared FDA 510(k) K172556

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TubeClear
Generic name
Enteral feeding/decompression tube clearing stem
Model / reference
NE-1048
Primary DI / UDI-DI
00850458007485
510(k) Number
FDA product code
FPD, KNT
GMDN term
Enteral feeding/decompression tube clearing stem
Device class
Class II
Regulation number
876.5980
GUDID distribution status
In Commercial Distribution

Related devices

Category: Enteral feeding/decompression tube clearing stemEnteral feeding/decompression tube clearing actuator

Cleared under the same submission (K131052)

and 8 more cleared under K131052

Cleared under the same submission (K172556)

and 8 more cleared under K172556

Similar devices

Also classified as Enteral feeding/decompression tube clearing actuator.

Similar devices

Other devices filed under FDA product code FPD (Tube, Feeding).

Other devices from Actuated Medical, Inc.

See all devices from Actuated Medical, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)