510(k) · Cleared
ClearedOlympus Arthroscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · HRX Arthroscope
Cleared on Jun 14, 1995 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 14, 1995
- Review
- 82 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK951354 Olympus Arthroscopy SystemOlympus America, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK982133 Olympus Endoscopic System Lumbar Hernia Discectomy and Its Ancillary…The Olympus Optical Co. · 1998
- Descendant · cites it directly · 0 of its ownK160249 ULTRA TelescopesOlympus Winter & Ibe GmbH · 2016
- Descendant · 2 generations on · 0 of its ownK043128 Olympus EndoarmOlympus Corporation · 2004
Most influential descendants
Showing 3 of 3 · See all- K982133Olympus Endoscopic System Lumbar Hernia Discectomy and Its Ancillary EquipmentThe Olympus Optical Co. · 1998 · cites it directly1descendant
- K160249ULTRA TelescopesOlympus Winter & Ibe GmbH · 2016 · cites it directly0descendants
- K043128Olympus EndoarmOlympus Corporation · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951354 | Olympus Arthroscopy System | Olympus America, Inc. | 1995 | — |
| +1 | K982133 | Olympus Endoscopic System Lumbar Hernia Discectomy and Its Ancillary Equipment | The Olympus Optical Co. | 1998 | — |
| +1 | K160249 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | 2016 | — |
| +2 | K043128 | Olympus Endoarm | Olympus Corporation | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2016 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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?
- Of its descendants, K982133 (The Olympus Optical Co., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K951354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951354: Olympus Arthroscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951354
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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