510(k) · Cleared
ClearedEmbrace Thermoplastic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionix Development Corp. · IYE Accelerator, Linear, Medical
Cleared on May 3, 2012 as substantially equivalent to K022708 (Larson Products, Inc., 2002) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- May 3, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935067 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK935067 AquaplastWfr/Aquaplast Corp. · 1994
- 1 generation backK022708 KlarityLarson Products, Inc. · 2002
- This deviceK120335 Embrace ThermoplasticBionix Development Corp. · 2012
- Descendant · cites it directly · 0 of its ownK252174 AquaCast MaskBlessing Cathay Corporation · 2025
- Descendant · cites it directly · 0 of its ownK192102 Thermoplastic MasksAktina Medical Corporation · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935067 | Aquaplast | Wfr/Aquaplast Corp. | 1994 | — |
| −1 | K022708 | Klarity | Larson Products, Inc. | 2002 | — |
| 0 (this device) | K120335 | Embrace Thermoplastic | Bionix Development Corp. | 2012 | — |
| +1 | K252174 | AquaCast Mask | Blessing Cathay Corporation | 2025 | — |
| +1 | K192102 | Thermoplastic Masks | Aktina Medical Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K022708 | KlaritySummary page 2…ation number 892.5050, Accessory, Accelerator, Linear, Medical, and is classified as a Class 11 device. This device has been cleared by the FDA under K022708. b. Aquaplast Thermoplastic manufactured and legally marketed by WFRlAquaplast Corporation, Avondale, Pennsylva… | 2002 |
| * | K935067 | AquaplastSummary page 2…ation number 892.5050, Accessory, Accelerator, Linear, Medical, and is classified as a Class If device. This device has been cleared by the FDA under K935067. 5. Device Description: Embrace Thermoplastic from Bionix Development Corporation is a moldable low- temperature thermopl… | 1994 |
What descends from it? (2)
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252174 (Blessing Cathay Corporation, 2025) has gone furthest, with 0 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. 2012, this device’s year, is highlighted.
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?
Silhouette Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120335 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120335: Embrace Thermoplastic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120335
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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