# K092675: Grindcare

- Pathway: 510(k) (Traditional)
- Applicant: Medotech A/S
- Decided: Mar 3, 2010 after 183 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- 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 K842223 (1984). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030869: Bitestrip, S.L.P., Ltd. (2004) Summary page 3.
- K031998: Model J-5 Mvo-Monitor, Myotronics-Noromed, Inc. (2003) Summary page 3.
- K040849: Mentamove, Cole & Associates (2004) Summary page 3.

## Most influential descendants
- K163448: GrindCare System (2017), 0 descendants of its own
- K113677: Grindcare Measure (2012), 0 descendants of its own

## Indications for use
The GRINDCARE device is indicated to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep.

Source page: https://510kreport.com/device/K092675
Methodology: https://510kreport.com/methodology