510(k) · Cleared
ClearedMitek Arthroscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · HRX Arthroscope
Cleared on Apr 18, 2014 as substantially equivalent to K110097 (Acclarent, Inc., 2011) and 3 other predicates after a 116-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Apr 18, 2014
- Review
- 116 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K921244 (1992). 40 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 9 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 5 generations between
- 3 generations backK080622 Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc. · 2008
- 2 generations backK100577 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- 1 generation backK110097 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- This deviceK133941 Mitek ArthroscopesMedos International SARL · 2014
Show all 9 generations
- Root · 9 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 8 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 7 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 6 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 5 generations backK024095 Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2003
- 4 generations backK072073 Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with…Vision-Sciences, Inc. · 2007
- 3 generations backK080622 Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc. · 2008
- 2 generations backK100577 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- 1 generation backK110097 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- This deviceK133941 Mitek ArthroscopesMedos International SARL · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −8 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −7 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −6 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −5 | K024095 | Modification to Vision Sciences Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −4 | K072073 | Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System… | Vision-Sciences, Inc. | 2007 | — |
| −3 | K080622 | Entity Nasoview Led Nasopharyngoscope, Model 006105 | Optim, Inc. | 2008 | — |
| −2 | K100577 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| −1 | K110097 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| 0 (this device) | K133941 | Mitek Arthroscopes | Medos International SARL | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K110097 | Acclarent Cyclops Multi-Angle EndoscopeSummary page 1…Table 1: Predicate Devices Company Description 510(k) Acelarent Cyclops Multiangle Endloscope K110097 Acciarent Cyclops Multiangle Endloscope K100577 Stryker Stryker Arthroscope… | 2011 |
| * | K100577 | Acclarent Cyclops Multi-Angle EndoscopeSummary page 1…510(k) Acelarent Cyclops Multiangle Endloscope K110097 Acciarent Cyclops Multiangle Endloscope K100577 Stryker Stryker Arthroscope K(093677 Arthrex Arthrex Arthroscop… | 2011 |
| * | K093677 | Stryker ArthroscopeSummary page 1…ngle Endloscope K110097 Acciarent Cyclops Multiangle Endloscope K100577 Stryker Stryker Arthroscope K(093677 Arthrex Arthrex Arthroscopes K030096 Premarket Notification: Traditional 510(k) Mitek A… | 2010 |
| * | K030096 | Video Arthroscope, Models AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30…Summary page 1…angle Endloscope K100577 Stryker Stryker Arthroscope K(093677 Arthrex Arthrex Arthroscopes K030096 Premarket Notification: Traditional 510(k) Mitek Arthroscapes… | 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 22 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 40 ancestors has a recall of any class.
- 1 other device also cites its predicate K110097.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
Mitek Sports Medicine Arthroscopes are indicated for use in arthroscopic procedures (such as the knee, shoulder, hip, ankle, elbow) to provide visualization during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133941: Mitek Arthroscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133941
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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