510(k) · Cleared
ClearedNeurotech Medistim Plus, Type 291
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Research, Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Jul 11, 2002 after a 217-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.
- Decided
- Jul 11, 2002
- Review
- 217 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK014019 Neurotech Medistim Plus, Type 291Bio-Medical Research, Ltd. · 2002
- Descendant · cites it directly · 14 of its ownK082011 Medistim XP, Type 281 and Meditens XP, Type 458Bio-Medical Research, Ltd. · 2008
- Descendant · 2 generations on · 9 of its ownK110350 Kneehab XPBio-Medical Research, Ltd. · 2011
- Descendant · 2 generations on · 7 of its ownK150413 QB1 System Powered Muscle Stimulator & Transcutaneous Electrical…Cymedica Orthopedics, Inc. · 2015
- Descendant · 3 generations on · 4 of its ownK163067 CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK193275 Nerve and Muscle StimulatorShenzhen Xft Medical Limited · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K082011Medistim XP, Type 281 and Meditens XP, Type 458Bio-Medical Research, Ltd. · 2008 · cites it directly14descendants
- K110350Kneehab XPBio-Medical Research, Ltd. · 2011 · 2 generations on9descendants
- K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc. · 2015 · 2 generations on7descendants
- K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016 · 3 generations on4descendants
- K193275Nerve and Muscle StimulatorShenzhen Xft Medical Limited · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014019 | Neurotech Medistim Plus, Type 291 | Bio-Medical Research, Ltd. | 2002 | — |
| +1 | K082011 | Medistim XP, Type 281 and Meditens XP, Type 458 | Bio-Medical Research, Ltd. | 2008 | — |
| +2 | K110350 | Kneehab XP | Bio-Medical Research, Ltd. | 2011 | — |
| +2 | K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve… | Cymedica Orthopedics, Inc. | 2015 | — |
| +3 | K163067 | CyMedica e-vive™ System; CY-1000 | Cymedica Orthopedics, Inc. | 2016 | — |
| +2 | K193275 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 19.7 · 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 |
|---|---|---|---|
| * | — | Stadyn EMS+2 Named without a submission number |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082011 | Medistim XP, Type 281 and Meditens XP, Type 458 | 2008 | 14 |
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?
- Of its descendants, K082011 (Bio-Medical Research, Ltd., 2008) has gone furthest, with 14 descendants 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.
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 MediStim PLUS i s indicated for:
Relaxakion of musde spasms
Prevention or retardation of disuse atrophy
Increasing locaI blood circuhtion
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent
venous thrombosis
Maintaining or increasing range of motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014019 · printed Nov 4, 2026
Cite this page
510(k) Report. “K014019: Neurotech Medistim Plus, Type 291.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014019
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026