510(k) · Cleared
ClearedKlarity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Larson Products, Inc. · IYE Accelerator, Linear, Medical
Cleared on Nov 12, 2002 as substantially equivalent to K935067 (Wfr/Aquaplast Corp., 1994) after a 90-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Nov 12, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935067 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK935067 AquaplastWfr/Aquaplast Corp. · 1994
- This deviceK022708 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935067 | Aquaplast | Wfr/Aquaplast Corp. | 1994 | — |
| 0 (this device) | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K935067 | AquaplastSummary page 1…plastTMThermoplastic, manufactured and sold b j WFR Aquaplast Corporation, based in Lawlins Park, New Jcrsej. Aquaplastl\‘ is rcgistered under 51 O(k) Number K935067. Klarit! is a ”IOU temperature’’ Thermoplastic, which is pliant and moldable by hand \\lien Iieatcd to a tempera… | 1994 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120335 | Embrace Thermoplastic | 2012 | 2 |
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?
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 | — |
What is it indicated for?
Klarity Thermoplastic is to be used by, or under the supervision of licensed physicians for the stabilization of patients undergoing external beam Radiation Therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022708: Klarity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022708
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026