510(k) · Cleared
Clearedgeko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Firstkind Limited · IPF Stimulator, Muscle, Powered
Cleared on Apr 10, 2017 as substantially equivalent to K152677 (Firstkind Limited, 2015) and 1 other predicate after a 153-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Apr 10, 2017
- Review
- 153 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K880235 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK880235 Intelect Model 120Chattanooga Group, Inc. · 1988
- 4 generations backK031017 Sys*Stim 208 and 208AMettler Electronics Corp. · 2003
- 3 generations backK133638 GEKOFirstkind Limited · 2014
- 2 generations backK152677 geko T-2 Neuromuscular StimulatorFirstkind Limited · 2015
- 1 generation backK160299 geko (TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited · 2016
- This deviceK163125 geko™ T-2 and geko™ Plus R-2 Neuromuscular StimulatorsFirstkind Limited · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K880235 | Intelect Model 120 | Chattanooga Group, Inc. | 1988 | — |
| −4 | K031017 | Sys*Stim 208 and 208A | Mettler Electronics Corp. | 2003 | — |
| −3 | K133638 | GEKO | Firstkind Limited | 2014 | — |
| −2 | K152677 | geko T-2 Neuromuscular Stimulator | Firstkind Limited | 2015 | — |
| −1 | K160299 | geko (TM) Plus R-2 Neuromuscular Stimulator | Firstkind Limited | 2016 | — |
| 0 (this device) | K163125 | geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators | Firstkind Limited | 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 IPF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.6 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K152677 | geko T-2 Neuromuscular StimulatorSummary page 4…wered Product Code, CFR: IPF, 21 CFR 890.5850 Panel code: 89 Class: II D. Predicate Devices: K152677 for geko™ T-2 K160299 for geko™ Plus R-2 E. Device Description: The geko™ T-2 and geko™ P… | 2015 |
| * | K160299 | geko (TM) Plus R-2 Neuromuscular StimulatorSummary page 4…890.5850 Panel code: 89 Class: II D. Predicate Devices: K152677 for geko™ T-2 K160299 for geko™ Plus R-2 E. Device Description: The geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulator devices were pr… | 2016 |
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K152677.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
Increasing local blood circulation
Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163125: geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163125
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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