510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K843011Substantially Equivalent

Term Guard 5000 Uterine Activity

Tokos Medical Corp., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843011 is the FDA 510(k) clearance record for TERM GUARD 5000 UTERINE ACTIVITY, a class II device, cleared for Tokos Medical Corp. on under FDA product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)). FDA records list 2 510(k) clearances for Tokos Medical Corp., from to . As of , FDA records show no recalls naming K843011.

Clearance record

Decision date
Received
(93 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
Tokos Medical Corp. 1200 18 St. Nw, Washington DC
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