510(k) · Cleared
ClearedFotomaster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamilton Thorne Research · LLZ System, Image Processing, Radiological
Cleared on May 3, 2000 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 3, 2000
- Review
- 86 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK000380 FotomasterHamilton Thorne Research · 2000
- Descendant · cites it directly · 3 of its ownK011944 Dyonics Vision 635 Digital Capture System, Model 7209088Smith & Nephew, Inc. · 2001
- Descendant · 2 generations on · 0 of its ownK030728 Fyrelink VLMpacs, LLC · 2003
- Descendant · 2 generations on · 0 of its ownK023053 Dyonics Vision 635 Image Management SystemSmith & Nephew, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK021236 Surgery and AccessoriesCamtronics, Ltd. · 2002
Most influential descendants
Showing 4 of 4 · See all- K011944Dyonics Vision 635 Digital Capture System, Model 7209088Smith & Nephew, Inc. · 2001 · cites it directly3descendants
- K030728Fyrelink VLMpacs, LLC · 2003 · 2 generations on0descendants
- K023053Dyonics Vision 635 Image Management SystemSmith & Nephew, Inc. · 2002 · 2 generations on0descendants
- K021236Surgery and AccessoriesCamtronics, Ltd. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000380 | Fotomaster | Hamilton Thorne Research | 2000 | — |
| +1 | K011944 | Dyonics Vision 635 Digital Capture System, Model 7209088 | Smith & Nephew, Inc. | 2001 | — |
| +2 | K030728 | Fyrelink VL | Mpacs, LLC | 2003 | — |
| +2 | K023053 | Dyonics Vision 635 Image Management System | Smith & Nephew, Inc. | 2002 | — |
| +2 | K021236 | Surgery and Accessories | Camtronics, Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011944 | Dyonics Vision 635 Digital Capture System, Model 7209088 | 2001 | 3 |
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, K011944 (Smith & Nephew, Inc., 2001) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
https://510kreport.com/device/K000380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000380: Fotomaster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000380
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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