510(k) · Cleared
ClearedMedline DeNovo 4Pro Electrical Stimulation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Sep 21, 2020 as substantially equivalent to K080950 (Otto Bock, Austria GmbH, 2009) and 1 other predicate after a 130-day review. Its family tree reaches back 7 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 21, 2020
- Review
- 130 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930530 (1995). 24 ancestors in all, the oldest K813008 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 6 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 5 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 4 generations backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 3 generations backK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- 2 generations backK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- 1 generation backK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- This deviceK201290 Medline DeNovo 4Pro Electrical Stimulation DeviceMedline Industries, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK243079 NeuroTrac® MyoPlus Pro (MYO120U)Verity Medical, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK213043 Levator Elite (Model LE9011)Shenzhen Dongdixin Technology Co., Ltd. · 2022
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 |
|---|---|---|---|---|---|
| −7 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −6 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −5 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −4 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| −3 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| −2 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| −1 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| 0 (this device) | K201290 | Medline DeNovo 4Pro Electrical Stimulation Device | Medline Industries, Inc. | 2020 | — |
| +1 | K243079 | NeuroTrac® MyoPlus Pro (MYO120U) | Verity Medical, Ltd. | 2025 | — |
| +1 | K213043 | Levator Elite (Model LE9011) | Shenzhen Dongdixin Technology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K080950 | Stiwell MED4Summary page 5…s: Class II Regulation #: 21 CFR 890.5850, 876.5320, 882.5890, 882.5050, 882.5810 Predicate Device Primary Predicate: Otto Bock Healthcare Product GmbH – STIWELL med4 – K080950 Secondary Predicate: Thought Technology Ltd. – MyoTrac Infiniti Electrical Stimulator – K053434… | 2009 |
| * | K053434 | Myotrac Infiniti Electrical StimulatorSummary page 5…ce Primary Predicate: Otto Bock Healthcare Product GmbH – STIWELL med4 – K080950 Secondary Predicate: Thought Technology Ltd. – MyoTrac Infiniti Electrical Stimulator – K053434 1 Device Description The Medline DeNovo 4Pro Electrical Stimulatio… | 2006 |
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 25 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 24 ancestors has a recall.
- Of its descendants, K243079 (Verity Medical, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K080950.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
For EMG mode: - Relaxation muscle training and muscle re-education For NMES (also known as STIM) mode: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion - Muscle Re-Education For TENS mode: - Symptomatic relief and management of chronic (long-term), intractable pain -…
Read the full statement (157 words)
For EMG mode:
- Relaxation muscle training and muscle re-education
For NMES (also known as STIM) mode:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
- Muscle Re-Education
For TENS mode:
- Symptomatic relief and management of chronic (long-term), intractable pain
- Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
For EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only):
- Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles
- Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal)
For FES
- Helps to relearn voluntary motor functions of the extremities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201290: Medline DeNovo 4Pro Electrical Stimulation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201290
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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