510(k) · Cleared
ClearedCrystal Vision and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I.C Medical, Inc. · FYD Apparatus, Exhaust, Surgical
Cleared on Feb 18, 1994 after a 287-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
- Feb 18, 1994
- Review
- 287 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK932230 Crystal Vision and AccessoriesI.C Medical, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK163659 Crystal VisionI.C Medical, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK200250 Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap…Megadyne Medical Products, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK960492 SI Controller Model SI 500I.C Medical, Inc. · 1996
Most influential descendants
Showing 3 of 3 · See all- K163659Crystal VisionI.C Medical, Inc. · 2017 · cites it directly1descendant
- K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable…Megadyne Medical Products, Inc. · 2020 · 2 generations on0descendants
- K960492SI Controller Model SI 500I.C Medical, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932230 | Crystal Vision and Accessories | I.C Medical, Inc. | 1994 | — |
| +1 | K163659 | Crystal Vision | I.C Medical, Inc. | 2017 | — |
| +2 | K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne… | Megadyne Medical Products, Inc. | 2020 | — |
| +1 | K960492 | SI Controller Model SI 500 | I.C Medical, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 FYD? 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 FYD device
- #1 K240127 PlumeSafe X5 Smoke Management Systemscore 8.7 · 4 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, K163659 (I.C Medical, Inc., 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FYD devicesFYD Apparatus, Exhaust, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FYD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FYD
71in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYD
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FYD
15in 2025
MAUDE reports naming product code FYD, 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 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 39 |
| 2011 | 0 | — | 0 | 150 |
| 2012 | 0 | — | 0 | 120 |
| 2013 | 0 | — | 0 | 142 |
| 2014 | 1 | — | 0 | 71 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 3 | 71 | 0 | 11 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 20 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 3 | — |
https://510kreport.com/device/K932230 · printed Nov 4, 2026
Cite this page
510(k) Report. “K932230: Crystal Vision and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K932230
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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