510(k) · Cleared
ClearedArthrex AR-8200 Shaver System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Cleared on Jan 25, 1994 after a 236-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jan 25, 1994
- Review
- 236 days
- Class
- Class I
- Product code
- HWE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK932699 Arthrex AR-8200 Shaver SystemArthrex, Inc. · 1994
- Descendant · cites it directly · 6 of its ownK041824 X-Treme Arthroscopic Pump and Shaver SystemFuture Medical Systems, SA · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK050580 Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK051326 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 0 of its ownK171794 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK131191 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM…Depuy Mitek, A Johnson & Johnson Company · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K041824X-Treme Arthroscopic Pump and Shaver SystemFuture Medical Systems, SA · 2005 · cites it directly6descendants
- K050580Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc. · 2005 · 2 generations on2descendants
- K051326Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2005 · 3 generations on1descendant
- K171794Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2017 · 4 generations on0descendants
- K1311914MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado Bur Plus…Depuy Mitek, A Johnson & Johnson Company · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932699 | Arthrex AR-8200 Shaver System | Arthrex, Inc. | 1994 | — |
| +1 | K041824 | X-Treme Arthroscopic Pump and Shaver System | Future Medical Systems, SA | 2005 | 2 |
| +2 | K050580 | Smith & Nephew Intelijet Fluid Management Systems | Smith & Nephew Endoscopy, Inc. | 2005 | — |
| +3 | K051326 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | 2005 | 6 |
| +4 | K171794 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | 2017 | — |
| +2 | K131191 | 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado… | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWE? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041824 | X-Treme Arthroscopic Pump and Shaver System | 2005 | 6 |
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?
- Of its descendants, K041824 (Future Medical Systems, SA, 2005) has gone furthest, with 6 descendants of its own.
How does its category compare?
All HWE devicesHWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HWE
Too few HWE 510(k)s in any year since 2007 to give a median.
Recalls per year · HWE
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWE
2,848in 2025
MAUDE reports naming product code HWE, 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 | 123 |
| 2008 | 0 | — | 0 | 72 |
| 2009 | 0 | — | 4 | 180 |
| 2010 | 0 | — | 2 | 297 |
| 2011 | 1 | — | 2 | 138 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 1,243 |
| 2014 | 0 | — | 3 | 3,794 |
| 2015 | 1 | — | 5 | 5,567 |
| 2016 | 0 | — | 2 | 4,974 |
| 2017 | 0 | — | 1 | 5,074 |
| 2018 | 0 | — | 0 | 3,589 |
| 2019 | 0 | — | 0 | 3,452 |
| 2020 | 0 | — | 0 | 3,248 |
| 2021 | 0 | — | 0 | 3,140 |
| 2022 | 0 | — | 0 | 3,327 |
| 2023 | 0 | — | 0 | 3,397 |
| 2024 | 0 | — | 0 | 3,686 |
| 2025 | 0 | — | 0 | 2,848 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K932699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K932699: Arthrex AR-8200 Shaver System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932699
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026