510(k) · Cleared
ClearedDigit-Grip with LCD, Model Number DGR 002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nk Biotechnical Corp. · LBB Dynamometer, Ac-Powered
Cleared on Jul 17, 1998 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jul 17, 1998
- Review
- 63 days
- Class
- Class II
- Product code
- LBB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK981730 Digit-Grip with LCD, Model Number DGR 002Nk Biotechnical Corp. · 1998
- Descendant · cites it directly · 0 of its ownK012492 Kadance 2000Kada Research, Inc. · 2001
Most influential descendants
Showing 1 of 1 · See all- K012492Kadance 2000Kada Research, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981730 | Digit-Grip with LCD, Model Number DGR 002 | Nk Biotechnical Corp. | 1998 | — |
| +1 | K012492 | Kadance 2000 | Kada Research, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012492 | Kadance 2000 | 2001 | 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?
- Of its descendants, K012492 (Kada Research, Inc., 2001) has gone furthest, with 0 descendants of its own.
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?
INDICATIONS FOR USE: The ULTIMATE System is indicated for use as follows: 1. to measure grip or pinch strength in an injured and uninjured hand. 2. to follow an injury through the rehabilitation process and measure progress or lack of progress, in terms of grip or pinch strength, of the therapy regimen or medical treatment. 3. to document baseline grip or pinch strehglh of the hands and lifting, pulling and pushing strength capabilities of employees and…
Read the full statement (171 words)
INDICATIONS FOR USE: The ULTIMATE System is indicated for use as follows:
1. to measure grip or pinch strength in an injured and uninjured hand.
2. to follow an injury through the rehabilitation process and measure progress or lack of progress, in terms of grip or pinch strength, of the therapy regimen or medical treatment.
3. to document baseline grip or pinch strehglh of the hands and lifting, pulling and pushing strength capabilities of employees and to monitor the strength of employees in the workplace over time.
4. generally, in 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 to his/her hand(s).
5. 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 (lifting, pulling and pushing protocols) in a simulated test.
6. to conduct pre-employment screening for physically demanding job activities.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981730 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981730: Digit-Grip with LCD, Model Number DGR 002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981730
Report an extraction error
Are you the manufacturer?
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