510(k) · Cleared
ClearedSeries Ten Thousand Master
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperVision, Inc. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on Jul 11, 1986 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jul 11, 1986
- Review
- 88 days
- Class
- Class II
- Product code
- HQE
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK861380 Series Ten Thousand MasterCooperVision, Inc. · 1986
- Descendant · cites it directly · 4 of its ownK030179 Medisiss Phacoemulsification Tips/NeedlesSurgical Instruments Service and Savings, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 3 of its ownK041841 PachycamOculus Optikgerate GmbH · 2005
- Descendant · cites it directly · 2 of its ownK955789 Alcon Series 20000 Legacy Mackool SystemAlcon Laboratories · 1996
- Descendant · 3 generations on · 1 of its ownK073508 ParkoneOculus Optikgerate GmbH · 2008
- Descendant · 4 generations on · 0 of its ownK202989 Myopia MasterOculus Optikgeräte GmbH · 2021 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K030179Medisiss Phacoemulsification Tips/NeedlesSurgical Instruments Service and Savings, Inc. · 2003 · cites it directly4descendants
- K041841PachycamOculus Optikgerate GmbH · 2005 · 2 generations on3descendants
- K955789Alcon Series 20000 Legacy Mackool SystemAlcon Laboratories · 1996 · cites it directly2descendants
- K073508ParkoneOculus Optikgerate GmbH · 2008 · 3 generations on1descendant
- K202989Myopia MasterOculus Optikgeräte GmbH · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861380 | Series Ten Thousand Master | CooperVision, Inc. | 1986 | — |
| +1 | K030179 | Medisiss Phacoemulsification Tips/Needles | Surgical Instruments Service and Savings, Inc. | 2003 | 1 |
| +2 | K041841 | Pachycam | Oculus Optikgerate GmbH | 2005 | — |
| +1 | K955789 | Alcon Series 20000 Legacy Mackool System | Alcon Laboratories | 1996 | — |
| +3 | K073508 | Parkone | Oculus Optikgerate GmbH | 2008 | — |
| +4 | K202989 | Myopia Master | Oculus Optikgeräte GmbH | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 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 HQE? 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 HQE device
- #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
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? (8)
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, K030179 (Surgical Instruments Service and Savings, Inc., 2003) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HQE devicesHQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQE
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQE
Too few HQE 510(k)s in any year since 2007 to give a median.
Recalls per year · HQE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQE
339in 2025
MAUDE reports naming product code HQE, 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 | 0 | — | 2 | 300 |
| 2008 | 0 | — | 0 | 65 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 11 | 27 |
| 2011 | 1 | — | 0 | 21 |
| 2012 | 2 | — | 0 | 34 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 4 | 10 |
| 2017 | 1 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 309 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 105 |
| 2025 | 0 | — | 1 | 339 |
| 2026 | 0 | — | 3 | — |
https://510kreport.com/device/K861380 · printed Nov 5, 2026
Cite this page
510(k) Report. “K861380: Series Ten Thousand Master.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K861380
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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