# K982651: Corometrics Model 5700 and 2264 Watertight Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Corometrics Medical Systems, Inc.
- Decided: Dec 11, 1998 after 134 days
- Product code: HEL (Monitor, Heart Rate, Fetal, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 884.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K891595 (1989). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891595: Model 116 Fetal Monitor, Ge Medical Systems Information Technologies (1989) Summary page 1.
- K942887: Model M1310A, Series 50T Fetal Telemetry System, Hewlett-Packard Co. (1994) Summary page 1.

## Most influential descendants
- K061044: Featherlite Aqua Tocodynamometer (2006), 0 descendants of its own
- K040392: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring (2004), 0 descendants of its own
- K040819: Transducer for Ultrasound Fetal Monitoring, Models FM10833 and FM10834 (2004), 0 descendants of its own

## Indications for use
Use of the Model 5700 and 2264 Series Non-Invasive Watertight Transducers are indicated as accessories to Corometrics Fetal and Fetal/Maternal Monitors. The Model 5700 Watertight Transducer provides for the detection of fetal heart rate and the Model 2264 Watertight Transducer provides for the detection of uterine activity. Both transducers are intended to be used in either water or non-water environments. When used in water environment applications both transducers are intended to be directly connected to telemetry and not directly connected to a Fetal or Fetal /Maternal monitor or any AC powered monitoring devices. Labeling and labels, on the transducers themselves, instruct the care provider to directly connect the transducers to a telemetry system when the devices are exposed to a water environment.

Source page: https://510kreport.com/device/K982651
Methodology: https://510kreport.com/methodology