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Mdrive

by Embla Systems

510(k) K111742

Mdrive is a Class II device made by Embla Systems, cleared under FDA 510(k) K111742 on 31 Aug 2011, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 · Special NumberK111742 Date31 Aug 2011ClearedStatusActive

Official records

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  • Withdrawn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
MNR
Device class
Class II
Regulation
21 CFR Part 868.2375
Advisory committee
Anesthesiology
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

Cited by

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

Devices cleared under K111742

3 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 K111742
UDI-DISize and differences
Natus 2013001
XLTEK
201300100382830023955 —No longer on the market
Natus 2020011
XLTEK
202001100382830059251 —No longer on the market
Natus 2040001
XLTEK
204000100382830023986 —No longer on the market

Similar devices

Other devices filed under FDA product code MNR (Ventilatory Effort Recorder).

Other devices from Embla Systems

See all devices from Embla Systems →