510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081767Substantially Equivalent

Amnisure Fetal Membranes Rupture Test, Model Fmrt-1

Amnisure International, LLC, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K081767 is the FDA 510(k) clearance record for AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1, a class I device, cleared for Amnisure International, LLC on under FDA product code NQM (Immunoassay For Detection Of Amniotic Fluid Protein(S).). FDA's definition for product code NQM reads: "The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture". FDA records list one 510(k) clearance for Amnisure International, LLC. As of , FDA records show 2 recalls naming K081767.

Clearance record

Decision date
Received
(203 days to decision)
Product code
NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).
Regulation
21 CFR 862.1550
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Amnisure International, LLC 30 Jfk St. , 4th Floor, Cambridge MA
510(k) summary
Statement
Third party review
No

Clearances, product code NQM

Trailing 12 months

FDA records hold no clearances under product code NQM in the trailing twelve months.

FDA records show no clearances under product code NQM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NQM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260