510(k) · Cleared
ClearedBionicare Stimilator System, Model Bio-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Murray Electronics · NYN Stimulator, Electrical, Transcutaneous, For Arthritis
Cleared on Mar 15, 1999 as substantially equivalent to K971437 (Murray Electronics, 1997) after a 181-day review. Its family tree reaches back 1 generation to 1997. 7 later devices descend from it.
- Decided
- Mar 15, 1999
- Review
- 181 days
- Class
- Class II
- Product code
- NYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971437 (1997). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK971437 Bionicare Stimulator System. Model Bio-1000Murray Electronics · 1997
- This deviceK983228 Bionicare Stimilator System, Model Bio-1000Murray Electronics · 1999
- Descendant · cites it directly · 3 of its ownK052625 Bionicare Stimulator System, Model Bio-1000Bionicare Medical Technologies, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK060669 Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300Healthonics, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK073386 Joint Stim, Model 1000Pain Management Technologies · 2008
- Descendant · 2 generations on · 0 of its ownK142236 BioniCare Hand SystemVision Quest Industries, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK111557 X-ForceSeven Seas Distribtion and Manufacturing, LLC · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K052625Bionicare Stimulator System, Model Bio-1000Bionicare Medical Technologies, Inc. · 2005 · cites it directly3descendants
- K060669Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300Healthonics, Inc. · 2006 · cites it directly2descendants
- K073386Joint Stim, Model 1000Pain Management Technologies · 2008 · 2 generations on1descendant
- K142236BioniCare Hand SystemVision Quest Industries, Inc. · 2015 · 2 generations on0descendants
- K111557X-ForceSeven Seas Distribtion and Manufacturing, LLC · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971437 | Bionicare Stimulator System. Model Bio-1000 | Murray Electronics | 1997 | — |
| 0 (this device) | K983228 | Bionicare Stimilator System, Model Bio-1000 | Murray Electronics | 1999 | — |
| +1 | K052625 | Bionicare Stimulator System, Model Bio-1000 | Bionicare Medical Technologies, Inc. | 2005 | — |
| +1 | K060669 | Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300 | Healthonics, Inc. | 2006 | — |
| +2 | K073386 | Joint Stim, Model 1000 | Pain Management Technologies | 2008 | — |
| +2 | K142236 | BioniCare Hand System | Vision Quest Industries, Inc. | 2015 | — |
| +3 | K111557 | X-Force | Seven Seas Distribtion and Manufacturing, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K971437 | Bionicare Stimulator System. Model Bio-1000Summary page 1…ulator for pain relief (21CFR§ 882.5890, class II). 3.0 Identification of Predicate Device Bionicare® Stimulator System, Model BIO-1000™ Murray Electronics 510(k) NumberK971437, July 22, 1997 40 Device Description The Bionicare®Stimulator System, Model BIO-1000™ is a rechargeable battery operated TENS s… | 1997 |
What descends from it? (7)
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?
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 System 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/K983228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983228: Bionicare Stimilator 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/K983228
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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