510(k) · Cleared
Clearedgeko T-2 and geko Plus R-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Firstkind, Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Feb 11, 2018 as substantially equivalent to K162987 (Flowaid Medical Technologies, Corp, 2017) after a 31-day review. Its family tree reaches back 3 generations to 1987. 4 later devices descend from it.
- Decided
- Feb 11, 2018
- Review
- 31 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K872976 (1987). 7 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK872976 Tens Pals PlusAxelgaard Mfg. Co., Ltd. · 1987
- 2 generations backK050046 Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SCompex Technologies, Inc. · 2005
- 1 generation backK162987 FA100 SCCD (Sequential Continuous Contraction Device)Flowaid Medical Technologies, Corp · 2017
- This deviceK180082 geko T-2 and geko Plus R-2Firstkind, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK193045 geko™ W-2Firstkind Limited · 2020
- Descendant · cites it directly · 1 of its ownK181059 geko T-3 Neuromuscular StimulatorFirstkind Limited · 2018
- Descendant · 2 generations on · 0 of its ownK212762 geko W-2Firstkind Limited · 2021
- Descendant · cites it directly · 0 of its ownK191113 geko T-2 and geko T-3 Neuromuscular StimulatorsFirstkind Limited · 2019
Most influential descendants
Showing 4 of 4 · See all- K193045geko™ W-2Firstkind Limited · 2020 · cites it directly1descendant
- K181059geko T-3 Neuromuscular StimulatorFirstkind Limited · 2018 · cites it directly1descendant
- K212762geko W-2Firstkind Limited · 2021 · 2 generations on0descendants
- K191113geko T-2 and geko T-3 Neuromuscular StimulatorsFirstkind Limited · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872976 | Tens Pals Plus | Axelgaard Mfg. Co., Ltd. | 1987 | — |
| −2 | K050046 | Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S | Compex Technologies, Inc. | 2005 | — |
| −1 | K162987 | FA100 SCCD (Sequential Continuous Contraction Device) | Flowaid Medical Technologies, Corp | 2017 | — |
| 0 (this device) | K180082 | geko T-2 and geko Plus R-2 | Firstkind, Ltd. | 2018 | — |
| +1 | K193045 | geko™ W-2 | Firstkind Limited | 2020 | — |
| +1 | K181059 | geko T-3 Neuromuscular Stimulator | Firstkind Limited | 2018 | — |
| +2 | K212762 | geko W-2 | Firstkind Limited | 2021 | — |
| +1 | K191113 | geko T-2 and geko T-3 Neuromuscular Stimulators | Firstkind Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K162987 | FA100 SCCD (Sequential Continuous Contraction Device)Summary page 4…IPF, 21 CFR 890.5850 Panel code: 89 Class: II D. Predicate Device: K162987 for FlowAid FA100 SCCD E. Device Description: The geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulator devices were… | 2017 |
What descends from it? (4)
3 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 31 years and passes through 4 companies; a new generation was cleared every 11.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K193045 (Firstkind Limited, 2020) 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. 2018, 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
• Edema reduction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180082: geko T-2 and geko Plus R-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180082
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