510(k) · Cleared
ClearedGrayDuck Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Poll Medical, LLC · IYE Accelerator, Linear, Medical
Cleared on Feb 26, 2019 as substantially equivalent to K153270 (Bionix Development Corp., 2016) after an 82-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Feb 26, 2019
- Review
- 82 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K934523 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK934523 Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth…Radionics, Inc. · 1995
- 2 generations backK962155 Gill-Thomas-Cosman (GTC) Dental TrayRadionics Software Applications, Inc. · 1996
- 1 generation backK153270 TruGuard Custom Tongue and Jaw PositionerBionix Development Corp. · 2016
- This deviceK183374 GrayDuck StentPoll Medical, LLC · 2019
- Descendant · cites it directly · 0 of its ownK232293 kallisio stentra™ oral stentKallisio, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK231852 BinkieRTPapricalab · 2023
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 |
|---|---|---|---|---|---|
| −3 | K934523 | Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth… | Radionics, Inc. | 1995 | — |
| −2 | K962155 | Gill-Thomas-Cosman (GTC) Dental Tray | Radionics Software Applications, Inc. | 1996 | — |
| −1 | K153270 | TruGuard Custom Tongue and Jaw Positioner | Bionix Development Corp. | 2016 | — |
| 0 (this device) | K183374 | GrayDuck Stent | Poll Medical, LLC | 2019 | — |
| +1 | K232293 | kallisio stentra™ oral stent | Kallisio, Inc. | 2023 | — |
| +1 | K231852 | BinkieRT | Papricalab | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K153270 | TruGuard Custom Tongue and Jaw PositionerSummary page 5…r) Classification Name: Patient Support Accessory to Accelerator, Linear, Medical Regulatory Class: 892.5050 Product Code: IYE 5.3. Legally Marketed Predicate Device K153270 Bionix Development Corporation’s TruGuard Custom Tongue and Jaw Positioner 5.4. Device Description The GrayDuck Stent™ custom t… | 2016 |
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 24 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232293 (Kallisio, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K153270.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 GrayDuck Stent™ custom tongue and jaw positioner from POLL Medical LLC is intended to be used for repeat positioning and immobilization of a patient’s tongue and jaw while undergoing or receiving a course of external beam radiation therapy for treatment of cancer and other diseases. The GrayDuck Stent is intended to be used by or under the direction of a licensed physician.
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/K183374 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183374: GrayDuck Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183374
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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