510(k) · Cleared
ClearedAquaplast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wfr/Aquaplast Corp. · IYE Accelerator, Linear, Medical
Cleared on May 26, 1994 after a 218-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 26, 1994
- Review
- 218 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK935067 AquaplastWfr/Aquaplast Corp. · 1994
- Descendant · cites it directly · 3 of its ownK022708 KlarityLarson Products, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK120335 Embrace ThermoplasticBionix Development Corp. · 2012
- Descendant · 2 generations on · 0 of its ownK252174 AquaCast MaskBlessing Cathay Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK192102 Thermoplastic MasksAktina Medical Corporation · 2019
Most influential descendants
Showing 4 of 4 · See all- K022708KlarityLarson Products, Inc. · 2002 · cites it directly3descendants
- K120335Embrace ThermoplasticBionix Development Corp. · 2012 · cites it directly2descendants
- K252174AquaCast MaskBlessing Cathay Corporation · 2025 · 2 generations on0descendants
- K192102Thermoplastic MasksAktina Medical Corporation · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935067 | Aquaplast | Wfr/Aquaplast Corp. | 1994 | — |
| +1 | K022708 | Klarity | Larson Products, Inc. | 2002 | — |
| +1 | K120335 | Embrace Thermoplastic | Bionix Development Corp. | 2012 | — |
| +2 | K252174 | AquaCast Mask | Blessing Cathay Corporation | 2025 | — |
| +2 | K192102 | Thermoplastic Masks | Aktina Medical Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
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, K022708 (Larson Products, Inc., 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
https://510kreport.com/device/K935067 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935067: Aquaplast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935067
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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