# K992811: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring

- Pathway: 510(k) (Abbreviated)
- Applicant: Epic Medical Equipment Services, Inc.
- Decided: Jan 18, 2000 after 151 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
Longest line of descent: 2 generations back to K911310 (1991). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843385: Corometrics 115 Fetal Monitor, Ge Medical Systems Information Technologies (1984) Summary page 1.
- K891595: Model 116 Fetal Monitor, Ge Medical Systems Information Technologies (1989) Summary page 1.
- K934959: Model 118 Fetal/Maternal Monitor, Ge Medical Systems Information Technologies (1994) Summary page 1.
- K964770: Corometrics 120 Series Maternal/Fetal Monitor, Ge Medical Systems Information Technologies (1997) Summary page 1.
- K900480: M1350A Fetal Monitor (Intrapartum), Hewlett-Packard Co. (1990) Summary page 1.
- (no number) Hewlett Packard Model 8040 (15245 & 15248): named in the summary without a submission number

## Most influential descendants
- K043075: Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring (2005), 0 descendants of its own
- K040392: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring (2004), 0 descendants of its own

## Indications for use
These devices are intended for use as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

Source page: https://510kreport.com/device/K992811
Methodology: https://510kreport.com/methodology