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Midmark M11-040

by Midmark Corporation

Midmark M11-040 is a Class II device made by Midmark Corporation, cleared under FDA 510(k) K163337 on 31 Aug 2017 and listed in FDA GUDID since 20 Aug 2020 (UDI-DI 00841709100277), 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) K163337

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 Number00841709100277 UDI-DI Date20 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK163337 Date31 Aug 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163337 decided 31 Aug 2017 Active
  • FDA GUDID UDI-DI 00841709100277 listed 20 Aug 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K163337
  2. Listed FDA GUDID 00841709100277

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Midmark
Generic name
Steam sterilizer
Model / Ref / Catalog
M11-040
Primary DI / UDI-DI
00841709100277
510(k) Number
FDA product code
FLE
GMDN term
Steam sterilizer
Device class
Class II
Regulation number
880.6880
GUDID distribution status
In Commercial Distribution

Related devices

Category: Steam sterilizer

Cleared under the same submission (K163337)

and 8 more cleared under K163337

Similar devices

Other devices filed under FDA product code FLE (Sterilizer, steam).

Other devices from Midmark Corporation

See all devices from Midmark Corporation →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)