510(k) · Cleared
ClearedDigital Hand Dynamometer, Model SH5003; Digital Pinch Gauge, Model SH5006
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saehan Corp. · LBB Dynamometer, Ac-Powered
Cleared on Sep 27, 2005 as substantially equivalent to K042889 (Ametek, 2004) after a 34-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Sep 27, 2005
- Review
- 34 days
- Class
- Class II
- Product code
- LBB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042889 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK042889 Dynamometer - Model Fce and Model MSCAmetek · 2004
- This deviceK052309 Digital Hand Dynamometer, Model SH5003; Digital Pinch Gauge, Model…Saehan Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042889 | Dynamometer - Model Fce and Model MSC | Ametek | 2004 | — |
| 0 (this device) | K052309 | Digital Hand Dynamometer, Model SH5003; Digital Pinch Gauge, Model SH5006 | Saehan Corp. | 2005 | — |
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 |
|---|---|---|---|
| * | K042889 | Dynamometer - Model Fce and Model MSCSummary page 1…e Devices : Manufacturer :Ametek, Inc. Device .Dynamometer(FCE Series) 5 10(k) Number : K042889(Docision Date-Nov. 16. 2004) 4. Classifications Names & Citations : 2LICFR 888.1240, LBB, DC-powered dynamometer, Clas… | 2004 |
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.
- 1 other device also cites its predicate K042889.
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?
The SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge are for performing manual muscle testing to measure grip or pinch strength in an injured and uninjured.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052309: Digital Hand Dynamometer, Model SH5003; Digital Pinch Gauge, Model SH5006.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052309
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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