510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994353Substantially Equivalent

Secureline Disposable Fetal Monitoring Straps #3860 and #3565

Precision Dynamics Corporation, San Fernando CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994353 is the FDA 510(k) clearance record for SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565, a class II device, cleared for Precision Dynamics Corp. on under FDA product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)). FDA records list 26 510(k) clearances for Precision Dynamics Corp., from to . As of , FDA records show no recalls naming K994353.

Clearance record

Decision date
Received
(90 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
Precision Dynamics Corp. 13880 Del Sur St., San Fernando CA
510(k) summary
Statement
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