510(k) · Cleared
ClearedHoggan Scientific® microFET2™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hoggan Scientific, LLC · LBB Dynamometer, Ac-Powered
Cleared on Mar 9, 2017 as substantially equivalent to K042889 (Ametek, 2004) after a 192-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Mar 9, 2017
- Review
- 192 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 deviceK162412 Hoggan Scientific® microFET2™Hoggan Scientific, LLC · 2017
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) | K162412 | Hoggan Scientific® microFET2™ | Hoggan Scientific, LLC | 2017 | — |
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 4…me: Dynamometer 21 CFR §888.1240, Product Code LBB, Class II Predicate Device(s): • K042889– Ametek, Inc., Dynamometer, Model Chatillon FCE and MSC series; Device Description: The mic… | 2004 |
| † | K860226 | Force Evaluation and Testing System (Fets) | 1986 |
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. 2017, this device’s year, is highlighted.
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 microFET2™ System is a dynamometer device for performing muscle tests to quantitatively measure muscle
weakness caused by injury or for sports medicine applications, as well as measure general muscle strength. The device is
used to record and convey an individual's ability to resist force for a specific muscle or muscle group being tested.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162412: Hoggan Scientific® microFET2™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162412
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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