510(k) · Cleared
ClearedKadance 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kada Research, Inc. · LBB Dynamometer, Ac-Powered
Cleared on Nov 2, 2001 as substantially equivalent to K981730 (Nk Biotechnical Corp., 1998) after a 91-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Nov 2, 2001
- Review
- 91 days
- Class
- Class II
- Product code
- LBB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981730 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981730 Digit-Grip with LCD, Model Number DGR 002Nk Biotechnical Corp. · 1998
- This deviceK012492 Kadance 2000Kada Research, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981730 | Digit-Grip with LCD, Model Number DGR 002 | Nk Biotechnical Corp. | 1998 | — |
| 0 (this device) | K012492 | Kadance 2000 | Kada Research, Inc. | 2001 | — |
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 LBB? 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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K981730 | Digit-Grip with LCD, Model Number DGR 002Summary page 1…prietary Name: KaDance Hand Sensor System Common Name: Force measurement device Classification Name; AC-powered dynamometer 3. Predicate Devices; Digit-grip with LCD K981730 4. Classifications Names & Citations: 21 CFR 888.1240 AC-powered dynamometer, Class |l, LLB, 87 Orthopedics. 5. Description:… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All LBB devicesLBB Dynamometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBB
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · LBB
Too few LBB 510(k)s in any year since 2007 to give a median.
Recalls per year · LBB
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBB
No MAUDE report names LBB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Any situation where the hand grip or pinch strength would be a valuable piece of data in the evaluation of a person who has sustained an injury or suffers a disease of his/her hand(s).
To measure grip or pinch strength in an injured and uninjured hand.
To conduct pre-employment screening for physically demanding job activities.
To establish an industrial strength testing program in general, and to match the strength of workers to the strength demands of specific job duties in the workplace.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012492 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012492: Kadance 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012492
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026