510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874631Substantially Equivalent

Healthphone Toco Model

Carelink, Laguna Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874631 is the FDA 510(k) clearance record for HEALTHPHONE TOCO MODEL, a class II device, cleared for Carelink on under FDA product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)). FDA records list 2 510(k) clearances for Carelink, from to . As of , FDA records show no recalls naming K874631.

Clearance record

Decision date
Received
(122 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
Carelink 22936 Mill Creek Dr., Laguna Hills CA
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