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MD Resource K Pump

by Medical Device Resource Corp.

MD Resource K Pump is a Class II device made by Medical Device Resource Corp., cleared under FDA 510(k) K012044 on 28 Aug 2001 and listed in FDA GUDID since 8 Sep 2016 (UDI-DI 00859898006423), 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) K012044

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 Number00859898006423 UDI-DI Date8 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK012044 Date28 Aug 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K012044 decided 28 Aug 2001 Active
  • FDA GUDID UDI-DI 00859898006423 listed 8 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K012044
  2. Listed FDA GUDID 00859898006423

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MD Resource
Generic name
Bedside infusion pump, single-channel
Model / Ref / Catalog
K Pump
Primary DI / UDI-DI
00859898006423
510(k) Number
FDA product code
FRN
GMDN term
Bedside infusion pump, single-channel
Device class
Class II
Regulation number
880.5725
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FRN (Pump, Infusion).

Other devices from Medical Device Resource Corp.

See all devices from Medical Device Resource Corp. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)