# K982635: Caredop II

- Pathway: 510(k) (Special)
- Applicant: Nicolet Biomedical
- Decided: Aug 7, 1998 after 25 days
- Product code: JAF (Monitor, Ultrasonic, Nonfetal)
- Device class: 2
- Regulation: 21 CFR 892.1540
- Recalls of this device: 4 (0 Class I)
- 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.

## Recalls of this device
- Jun 9, 2017 · Class II · Z-2727-2017: Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
- Jun 9, 2017 · Class II · Z-2726-2017: Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
- Jun 9, 2017 · Class II · Z-2728-2017: Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
- Jun 9, 2017 · Class II · Z-2729-2017: Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.

## Indications for use
Monitoring of blood flow in veins and arteries to assist in the detection of vascular disease and detection of early fetal heartbeat Instrument used in doctor’s office, clinic or hospital, by use for on the order of a physician. The device is for non-invasive use only. The device is not to be used on or near non-intact skin. The device is not to be used on or near the eyes. The device is to be used by or on order-of a physician.

Source page: https://510kreport.com/device/K982635
Methodology: https://510kreport.com/methodology