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Embletta Gold

by Embla Systems, Inc.

510(k) K073682

Embletta Gold is a Class II device made by Embla Systems, Inc., cleared under FDA 510(k) K073682 on 8 Aug 2008, 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 · Traditional NumberK073682 Date8 Aug 2008ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1532-2013 FDA Class II initiated 24 Apr 2013

    Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to over titrate the patient and prescribe a therapy pressure higher than is necessary.

Timeline

2 dated events

  1. Cleared FDA 510(k) K073682
  2. Recall initiated FDA recalls Z-1532-2013

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  • Withdrawn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

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

Cited by

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

Similar devices

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

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