510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110605Substantially Equivalent

Rom Plus

Clinical Innovations, LLC, Murray UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110605 is the FDA 510(k) clearance record for ROM PLUS, a class I device, cleared for Clinical Innovations, 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 18 510(k) clearances for Clinical Innovations, LLC, from to . As of , FDA records show one recall naming K110605.

Clearance record

Decision date
Received
(266 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
Clinical Innovations, LLC 747 W 4170 S, Murray UT
510(k) summary
Summary PDF
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