# K030869: Bitestrip

- Pathway: 510(k) (Traditional)
- Applicant: S.L.P., Ltd.
- Decided: May 14, 2004 after 422 days
- Product code: KZM (Device, Muscle Monitoring)
- Device class: 2
- Regulation: 21 CFR 890.1375
- 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 K874796 (1988). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992694: Modification to K6-I Diagnostic System, Model K6-I, Myotronics-Noromed, Inc. (1999) Summary page 5.
- K002135: Sleepstrip Disposable Apnea Screener, Influent, Ltd. (2000) Summary page 5.
- K874796: Model Eeg 4400 with Optional Accessories, Nihon Kohden America, Inc. (1988) Summary page 5.

## Most influential descendants
- K092675: Grindcare (2010), 2 descendants of its own
- K163448: GrindCare System (2017), 0 descendants of its own
- K113677: Grindcare Measure (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K030869
Methodology: https://510kreport.com/methodology