510(k) · Cleared
ClearedBlocking Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtec, Inc. · IYE Accelerator, Linear, Medical
Cleared on Nov 22, 1994 after an 85-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Nov 22, 1994
- Review
- 85 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK944315 Blocking TrayMedtec, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK991107 Shadow TraysMick Radio-Nuclear Instruments, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK023636 Blocking TraySoutheastern Radiation Products, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK964840 Beam Block TraysAktina Medical Physics Corp. · 1997
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 |
|---|---|---|---|---|---|
| 0 (this device) | K944315 | Blocking Tray | Medtec, Inc. | 1994 | — |
| +1 | K991107 | Shadow Trays | Mick Radio-Nuclear Instruments, Inc. | 1999 | — |
| +1 | K023636 | Blocking Tray | Southeastern Radiation Products, Inc. | 2002 | — |
| +1 | K964840 | Beam Block Trays | Aktina Medical Physics Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 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? (3)
3 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, K991107 (Mick Radio-Nuclear Instruments, Inc., 1999) has gone furthest, with 1 descendant 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/K944315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944315: Blocking Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944315
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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