510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140163Substantially Equivalent

Koala Toco

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

K140163 is the FDA 510(k) clearance record for KOALA TOCO, a class II device, cleared for Clinical Innovations, LLC on under FDA product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)). FDA records list 18 510(k) clearances for Clinical Innovations, LLC, from to . As of , FDA records show no recalls naming K140163.

Clearance record

Decision date
Received
(127 days to decision)
Product code
HFM Monitor, Uterine Contraction, External (For Use In Clinic)
Regulation
21 CFR 884.2720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Clinical Innovations, LLC 62 Forest St., Suite 300, Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HFM

Trailing 12 months

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

FDA records show no clearances under product code HFM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HFM, 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