# K994353: Secureline Disposable Fetal Monitoring Straps #3860 and #3565

- Pathway: 510(k) (Traditional)
- Applicant: Precision Dynamics Corp.
- Decided: Mar 22, 2000 after 90 days
- Product code: HFM (Monitor, Uterine Contraction, External (For Use In Clinic))
- Device class: 2
- Regulation: 21 CFR 884.2720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This product is to be used in a labor and delivery environment to secure a uterine contraction monitor to the mother's abdomen. The monitors are used to track contractions and baby’s heartbeat rate. Two styles of straps are available. The first contains a buttonhole and the second contains Velcro slots on each end (watchlike). Therefore, one style of strap contains multiple “button holes” for adjustment and the second style of strap is made with Velcro hook and loop for adjustment and securing. The straps are made of stretch fabric material and intended to be single-patient use. Both types of straps are packaged in pairs (one pink, one biue) shrink-wrapped and are available in quantities of fifty (50) pairs per box.

Source page: https://510kreport.com/device/K994353
Methodology: https://510kreport.com/methodology