510(k) · Cleared
Clearedgeko T-2 Neuromuscular Stimulator
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 Oct 23, 2015 as substantially equivalent to K133638 (Firstkind Limited, 2014) after a 35-day review. Its family tree reaches back 3 generations to 1988. 2 later devices descend from it.
- Decided
- Oct 23, 2015
- Review
- 35 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K880235 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK880235 Intelect Model 120Chattanooga Group, Inc. · 1988
- 2 generations backK031017 Sys*Stim 208 and 208AMettler Electronics Corp. · 2003
- 1 generation backK133638 GEKOFirstkind Limited · 2014
- This deviceK152677 geko T-2 Neuromuscular StimulatorFirstkind Limited · 2015
- Descendant · cites it directly · 1 of its ownK160299 geko (TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited · 2016
- Descendant · cites it directly · 0 of its ownK163125 geko™ T-2 and geko™ Plus R-2 Neuromuscular StimulatorsFirstkind Limited · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K880235 | Intelect Model 120 | Chattanooga Group, Inc. | 1988 | — |
| −2 | K031017 | Sys*Stim 208 and 208A | Mettler Electronics Corp. | 2003 | — |
| −1 | K133638 | GEKO | Firstkind Limited | 2014 | — |
| 0 (this device) | K152677 | geko T-2 Neuromuscular Stimulator | Firstkind Limited | 2015 | — |
| +1 | K160299 | geko (TM) Plus R-2 Neuromuscular Stimulator | Firstkind Limited | 2016 | — |
| +1 | K163125 | geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators | Firstkind Limited | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
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? (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 |
|---|---|---|---|
| * | K133638 | GEKOSummary page 4…Product Code, CFR: IPF, 21 CFR 890.5850 Panel code: 89 Class: II D. Predicate Device: K133638, geko™ T-1 Neuromuscular Stimulator E. Device Description: The geko™ T-2 Neuromuscular Stimulator (geko™ T-2) is a dispo… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K160299 (Firstkind Limited, 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The geko T-2 Neuromuscular Stimulator is intended for:
-Increasing local blood circulation; and
-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/K152677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152677: geko T-2 Neuromuscular Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152677
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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