510(k) · Cleared
ClearedkVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qfix · IYE Accelerator, Linear, Medical
Cleared on Dec 4, 2015 as substantially equivalent to K032156 (Wfr/Aquaplast Corp., 2003) after a 109-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Dec 4, 2015
- Review
- 109 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032156 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK032156 Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head…Wfr/Aquaplast Corp. · 2003
- This deviceK152321 kVue Encompass SRS Insert (Encompass Insert), Encompass SRS…Qfix · 2015
- Descendant · cites it directly · 0 of its ownK182189 Encompass SRS Headframe ; Encompass MR SRS HeadframeQfix · 2018
Most influential descendants
Showing 1 of 1 · See all- K182189Encompass SRS Headframe ; Encompass MR SRS HeadframeQfix · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032156 | Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head Board… | Wfr/Aquaplast Corp. | 2003 | — |
| 0 (this device) | K152321 | kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone… | Qfix | 2015 | — |
| +1 | K182189 | Encompass SRS Headframe ; Encompass MR SRS Headframe | Qfix | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K032156 | Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head Board with Shoulder…Summary page 6…Patient Immobilization System. The predicate device information follows: Predicate Device Name .| FDA Clearance . | Product | Manufacturer AccuFix Radiolucent Patient K032156, cleared WFR/AQUAPLAST e IYE Immobilization System September 2, 2003 CORP (Qfix) This predicate has not been subject to a desig… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182189 | Encompass SRS Headframe ; Encompass MR SRS Headframe | 2018 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K182189 (Qfix, 2018) 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. 2015, 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?
The Encompass™ SRS Immobilization System provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient’s features to provide accurate, reproducible positioning, repositioning and immobilization. The Encompass™ SRS Immobilization System allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152321: kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152321
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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