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Mtd 4000

by Mettler Electronics Corp.

510(k) K091540

Mtd 4000 is a medical device (FDA Class II; FDA product code ITH, Equipment, Traction, Powered) made by Mettler Electronics Corp., cleared under FDA 510(k) K091540 on 8 Oct 2009, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK091540 Date8 Oct 2009ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-2580-2011 FDA Unclassified (pre-2012) initiated 14 Apr 2011

    The recall was initiated because Mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding Electronics Traction Device - MTD4000. The firm are initiating the recall because component failure might result in patient injury. Use of the device should cease immediately.

Timeline

2 dated events

  1. Cleared FDA 510(k) K091540
  2. Recall initiated FDA recalls Z-2580-2011

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ITH
Device class
Class II
Regulation
21 CFR Part 890.5900
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K091540

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K091540
UDI-DISize and differences
Mettler ME4000
ZMI Electronics Ltd.
MTD4000 / ME400004719872330035
Prescription: no
On the market
MTD 4000 Digital Traction ME 4000
METTLER ELECTRONICS CORP.
ME 4000 / ME 400000816864020197
Weight 44 lb
Prescription: yes
On the market

Similar devices

Other devices filed under FDA product code ITH (Equipment, Traction, Powered).

Other devices from Mettler Electronics Corp.

See all devices from Mettler Electronics Corp. →