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Tetra Micro FP-0010216

by EMED Technologies Corporation

Tetra Micro FP-0010216 is a Class II device made by EMED Technologies Corporation, cleared under FDA 510(k) K251105 on 22 Dec 2025 and listed in FDA GUDID since 24 Feb 2026 (UDI-DI 00817708023428), 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) K251105

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 Number00817708023428 UDI-DI Date24 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251105 Date22 Dec 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251105 decided 22 Dec 2025 Active
  • FDA GUDID UDI-DI 00817708023428 listed 24 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251105
  2. Listed FDA GUDID 00817708023428

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tetra Micro
Generic name
Bedside infusion pump, single-channel
Model / Ref / Catalog
FP-0010216
Primary DI / UDI-DI
00817708023428
510(k) Number
FDA product code
PKP, FRN
GMDN term
Bedside infusion pump, single-channel
Device class
Class II
Regulation number
880.5725
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251105)

Similar devices

Other devices filed under FDA product code FRN.

Other devices from EMED Technologies Corporation

See all devices from EMED Technologies Corporation →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)