510(k) · Cleared
ClearedStella Bio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Egzotech Sp. Z O. O. · IPF Stimulator, Muscle, Powered
Cleared on Oct 1, 2021 as substantially equivalent to K080950 (Otto Bock, Austria GmbH, 2009) after a 270-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- Oct 1, 2021
- Review
- 270 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930530 (1995). 24 ancestors in all, the oldest K813008 (1981). 1 later device descends from it, 1 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 deviceK210002 Stella BioEgzotech Sp. Z O. O. · 2021
- Descendant · cites it directly · 0 of its ownK241488 TrainFES AdvanceTrainfes · 2025
Most influential descendants
Showing 1 of 1 · See all- K241488TrainFES AdvanceTrainfes · 2025 · cites it directly0descendants
View 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) | K210002 | Stella Bio | Egzotech Sp. Z O. O. | 2021 | — |
| +1 | K241488 | TrainFES Advance | Trainfes | 2025 | — |
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 |
|---|---|---|
| 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 19.7 · 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 |
|---|---|---|---|
| * | K080950 | Stiwell MED4Summary page 5…Manufacturer Regulation Product Code Clearance Date number device Number K080950 Stiwell med4 Otto Bock Healthcare 890.5850 IPF, GZJ, 2009-04-02 EGZOTech Sp. z o.o… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241488 | TrainFES Advance | 2025 | 0 |
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 26 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, K241488 (Trainfes, 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. 2021, 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 Prescription and Home Use by prescription from a medical professional: The Stella BIO is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions As a powered muscle stimulator, Stella BIO is indicated for the following conditions: • Relaxation of muscle spasms, • Prevention or retardation of disuse atrophy, • Increasing local blood circulation, •…
Read the full statement (281 words)
For Prescription and Home Use by prescription from a medical professional:
The Stella BIO is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions
As a powered muscle stimulator, Stella BIO is indicated for the following conditions:
• 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.
As a transcutaneous electrical nerve stimulator for pain relief, Stella BIO is indicated for the following conditions:
• Symptomatic relief and management of chronic (long-term), intractable pain,
• Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
As a biofeedback device, Stella BIO is indicated for:
• Biofeedback, relaxation, and muscle re- education.
As an external functional neuromuscular stimulator, Stella BIO is indicated for the following conditions:
• Helps to relearn voluntary motor functions of the extremities.
As a non-implanted electrical continence device, Stella BIO is indicated for the following conditions:
• Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: inhibition of the detrusor muscles through reflexive mechanisms and strengthening of pelvic floor muscles.
• Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as abdominal and the gluteus muscles.
Patient population: Stella BIO Prescription and Home Use by prescription from a medical professional can be used on adults aged 22 yrs and older.
Environments of Use: Clinics, hospital and home environments.
Platform: Stella BIO is a battery-powered, wireless device, accessible through software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210002: Stella Bio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210002
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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