510(k) · Cleared
ClearedBionicare Stimulator System, Model Bio-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionicare Medical Technologies, Inc. · NYN Stimulator, Electrical, Transcutaneous, For Arthritis
Cleared on Dec 5, 2005 as substantially equivalent to K030332 (Bionicare Medical Technologies, Inc., 2003) and 1 other predicate after a 73-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- Dec 5, 2005
- Review
- 73 days
- Class
- Class II
- Product code
- NYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971437 (1997). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971437 Bionicare Stimulator System. Model Bio-1000Murray Electronics · 1997
- 1 generation backK983228 Bionicare Stimilator System, Model Bio-1000Murray Electronics · 1999
- This deviceK052625 Bionicare Stimulator System, Model Bio-1000Bionicare Medical Technologies, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK073386 Joint Stim, Model 1000Pain Management Technologies · 2008
- Descendant · cites it directly · 0 of its ownK142236 BioniCare Hand SystemVision Quest Industries, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK111557 X-ForceSeven Seas Distribtion and Manufacturing, LLC · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971437 | Bionicare Stimulator System. Model Bio-1000 | Murray Electronics | 1997 | — |
| −1 | K983228 | Bionicare Stimilator System, Model Bio-1000 | Murray Electronics | 1999 | — |
| 0 (this device) | K052625 | Bionicare Stimulator System, Model Bio-1000 | Bionicare Medical Technologies, Inc. | 2005 | — |
| +1 | K073386 | Joint Stim, Model 1000 | Pain Management Technologies | 2008 | — |
| +1 | K142236 | BioniCare Hand System | Vision Quest Industries, Inc. | 2015 | — |
| +2 | K111557 | X-Force | Seven Seas Distribtion and Manufacturing, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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 NYN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K030332 | Modification to Bionicare Stimulator System, Model Bio-1000Summary page 1…ain relief, Class 11, 21 CFR 882.5890, Product Code GZJ Device: BioniCare®>~, Stimulator Model BIG-I OOOTM Predicate device: BioniCareCR Stimulator Model BlO-1000Tm, k030332 and k983228 Device Description: The BIO-1000 is a portable, rechargeable, battery-operated dual-channel device that utilizes a… | 2003 |
| * | K983228 | Bionicare Stimilator System, Model Bio-1000Summary page 1…Class 11, 21 CFR 882.5890, Product Code GZJ Device: BioniCare®>~, Stimulator Model BIG-I OOOTM Predicate device: BioniCareCR Stimulator Model BlO-1000Tm, k030332 and k983228 Device Description: The BIO-1000 is a portable, rechargeable, battery-operated dual-channel device that utilizes a voltage regu… | 1999 |
What descends from it? (3)
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 8 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073386 (Pain Management Technologies, 2008) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K030332.
How does its category compare?
All NYN devicesNYN Stimulator, Electrical, Transcutaneous, For Arthritis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NYN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NYN
Too few NYN 510(k)s in any year since 2007 to give a median.
Recalls per year · NYN
No recall names NYN since 2007.
Adverse event reports per year · NYN
1in 2012
MAUDE reports naming product code NYN, 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 | 1 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioniCare Stimulator, Model BIO-1000™, is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K052625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052625: Bionicare Stimulator System, Model Bio-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052625
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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