510(k) · Cleared
ClearedBioniCare Hand System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision Quest Industries, Inc. · NYN Stimulator, Electrical, Transcutaneous, For Arthritis
Cleared on Mar 23, 2015 as substantially equivalent to K052625 (Bionicare Medical Technologies, Inc., 2005) and 1 other predicate after a 222-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Mar 23, 2015
- Review
- 222 days
- Class
- Class II
- Product code
- NYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971437 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK971437 Bionicare Stimulator System. Model Bio-1000Murray Electronics · 1997
- 2 generations backK983228 Bionicare Stimilator System, Model Bio-1000Murray Electronics · 1999
- 1 generation backK052625 Bionicare Stimulator System, Model Bio-1000Bionicare Medical Technologies, Inc. · 2005
- This deviceK142236 BioniCare Hand SystemVision Quest Industries, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971437 | Bionicare Stimulator System. Model Bio-1000 | Murray Electronics | 1997 | — |
| −2 | K983228 | Bionicare Stimilator System, Model Bio-1000 | Murray Electronics | 1999 | — |
| −1 | K052625 | Bionicare Stimulator System, Model Bio-1000 | Bionicare Medical Technologies, Inc. | 2005 | — |
| 0 (this device) | K142236 | BioniCare Hand System | Vision Quest Industries, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K052625 | Bionicare Stimulator System, Model Bio-1000Summary page 4…For pain relief, Class II, 21 CFR 882.5890, Product Code NYN Predicate Devices: BioniCare® Stimulator, Model BIO-1000, k052625 and k030332 Device Description: The BioniCare Hand System, Model BIO-2000 is… | 2005 |
| * | K030332 | Modification to Bionicare Stimulator System, Model Bio-1000Summary page 4…roduct Code NYN Predicate Devices: BioniCare® Stimulator, Model BIO-1000, k052625 and k030332 Device Description: The BioniCare Hand System, Model BIO-2000 is portable, recha… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K052625.
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. 2015, this device’s year, is highlighted.
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 Hand System, Model BIO-2000, 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.
The BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in osteoarthritis of the hand to reduce the level of pain and stiffness and to improve the function of the hand.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142236: BioniCare Hand System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142236
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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