510(k) · Cleared

Cleared

Bitestrip

K030869510(k) TraditionalCleared May 14, 2004422-day reviewClass II21 CFR 890.1375

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

S.L.P., Ltd. · KZM Device, Muscle Monitoring

Cleared on May 14, 2004 as substantially equivalent to K992694 (Myotronics-Noromed, Inc., 1999) and 2 other predicates after a 422-day review. Its family tree reaches back 1 generation to 1988. 3 later devices descend from it.

Decided: May 14, 2004
Review: 422 days
Class: Class II
Product code: KZM
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K874796 (1988). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK874796 Model Eeg 4400 with Optional AccessoriesNihon Kohden America, Inc. · 1988
This deviceK030869 BitestripS.L.P., Ltd. · 2004
Descendant · cites it directly · 2 of its ownK092675 GrindcareMedotech A/S · 2010
Descendant · 2 generations on · 0 of its ownK163448 GrindCare SystemSunstar Suisse S.A. · 2017
Descendant · cites it directly · 0 of its ownK113677 Grindcare MeasureMedotech A/S · 2012

Most influential descendants

Showing 3 of 3 · See all

K092675GrindcareMedotech A/S · 2010 · cites it directly2descendants
K163448GrindCare SystemSunstar Suisse S.A. · 2017 · 2 generations on0descendants
K113677Grindcare MeasureMedotech A/S · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K874796	Model Eeg 4400 with Optional Accessories	Nihon Kohden America, Inc.	1988	—
0 (this device)	K030869	Bitestrip	S.L.P., Ltd.	2004	—
+1	K092675	Grindcare	Medotech A/S	2010	—
+2	K163448	GrindCare System	Sunstar Suisse S.A.	2017	—
+1	K113677	Grindcare Measure	Medotech A/S	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	1	0
2017	1	0

FIG. 1 — Lineage of K030869, 1988–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KZM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K992694	Modification to K6-I Diagnostic System, Model K6-I Summary page 5 …7-3 Predicate Device: * Model K6-I Diagnostic System (Myotronics-Noromed. Inc. USA) cleared under K992694 * SleepStrip® Influent Ltd., Israel cleared under K002135 * ELECTROENCEPHALOGRAPH, (Nihon-Kohden…	Myotronics-Noromed, Inc.	1999	—
*	K002135	Sleepstrip Disposable Apnea Screener Summary page 5 …Device: * Model K6-I Diagnostic System (Myotronics-Noromed. Inc. USA) cleared under K992694 * SleepStrip® Influent Ltd., Israel cleared under K002135 * ELECTROENCEPHALOGRAPH, (Nihon-Kohden America), cleared under K874796 Performance Standar…	Influent, Ltd.	2000	—
*	K874796	Model Eeg 4400 with Optional Accessories Summary page 5 …694 * SleepStrip® Influent Ltd., Israel cleared under K002135 * ELECTROENCEPHALOGRAPH, (Nihon-Kohden America), cleared under K874796 Performance Standards: The BiteStrip complies with the following recognized standards: EN 60601-1-1:90 + A1(93) + Al…	Nihon Kohden America, Inc.	1988	—

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K092675	Grindcare	Medotech A/S	2010	2
K113677	Grindcare Measure	Medotech A/S	2012	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K092675 (Medotech A/S, 2010) has gone furthest, with 2 descendants of its own.

How does its category compare?

All KZM devices

KZM Device, Muscle Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KZM

1in 2016

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KZM

Too few KZM 510(k)s in any year since 2007 to give a median.

Recalls per year · KZM

No recall names KZM since 2007.

Adverse event reports per year · KZM

No MAUDE report names KZM since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

https://510kreport.com/device/K030869 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030869: Bitestrip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030869

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026