Skip to content

Amnisure Fetal Membranes Rupture Test, Model Fmrt-1

by Amnisure International, LLC

510(k) K081767

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081767 Date9 Jan 2009ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1636-2020 FDA Class II initiated 21 Feb 2020

    An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.

    • Terminated Z-2577-2018 FDA Class I initiated 18 May 2018

    Potential for control line not appearing on the test strip

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  • Withdrawn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
NQM
Device Class
Class I
Regulation
21 CFR Part 862.1550
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent