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MedDrain 25298

by Armm Inc.

MedDrain 25298 is a Class I device made by Armm Inc., cleared under FDA 510(k) K931607 on 6 Aug 1993 and listed in FDA GUDID since 8 Jun 2023 (UDI-DI 10850005416026), active as of 23 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 23 Oct 2026

Documents

510(k) K931607

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10850005416026 UDI-DI Date8 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK931607 Date6 Aug 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K931607 decided 6 Aug 1993 Active
  • FDA GUDID UDI-DI 10850005416026 listed 8 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K931607
  2. Listed FDA GUDID 10850005416026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MedDrain
Generic name
Sump drain
Model / reference
25298
Primary DI / UDI-DI
10850005416026
510(k) Number
FDA product code
GBN
GMDN term
Sump drain
Device class
Class I
Regulation number
878.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sump drain

Cleared under the same submission (K931607)

and 5 more cleared under K931607

Other devices from Armm Inc.

See all devices from Armm Inc. →

Properties

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