510(k) · Cleared
ClearedHuestis Flexi-Board
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huestis Machine Corp. · JAD System, Therapeutic, X-Ray
Cleared on Nov 29, 1990 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Nov 29, 1990
- Review
- 92 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK904005 Huestis Flexi-BoardHuestis Machine Corp. · 1990
- Descendant · cites it directly · 2 of its ownK993400 HDR Contour TP Template and Implant AccessoriesMick Radio-Nuclear Instruments, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK991546 Aktina Medical Physics Corporation Tilt BoardAktina Medical Physics Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK150979 CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK032248 Precise Carbon Fiber Table Top, Model 11-999Aktina Medical Physics Corp. · 2003
- Descendant · 2 generations on · 0 of its ownK031273 Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K993400HDR Contour TP Template and Implant AccessoriesMick Radio-Nuclear Instruments, Inc. · 2000 · cites it directly2descendants
- K991546Aktina Medical Physics Corporation Tilt BoardAktina Medical Physics Corp. · 1999 · cites it directly1descendant
- K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. · 2016 · 2 generations on0descendants
- K032248Precise Carbon Fiber Table Top, Model 11-999Aktina Medical Physics Corp. · 2003 · 2 generations on0descendants
- K031273Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904005 | Huestis Flexi-Board | Huestis Machine Corp. | 1990 | — |
| +1 | K993400 | HDR Contour TP Template and Implant Accessories | Mick Radio-Nuclear Instruments, Inc. | 2000 | — |
| +1 | K991546 | Aktina Medical Physics Corporation Tilt Board | Aktina Medical Physics Corp. | 1999 | — |
| +2 | K150979 | CT/MR Compatible M.A.C. Interstitial GYN Template | Mick Radio-Nuclear Instruments, Inc. | 2016 | — |
| +2 | K032248 | Precise Carbon Fiber Table Top, Model 11-999 | Aktina Medical Physics Corp. | 2003 | — |
| +2 | K031273 | Ameritek Sure-Point HDR Needle Template | Amertek Medical, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2016 | 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 JAD? 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 JAD device
- #1 K241174 INTRABEAM (700); And accessories (INTRABEAM…score 11.7 · 11 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K993400 (Mick Radio-Nuclear Instruments, Inc., 2000) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAD
114in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAD
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAD
1in 2025
MAUDE reports naming product code JAD, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 106 | 2 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 3 |
| 2012 | 2 | — | 3 | 4 |
| 2013 | 5 | 114 | 0 | 12 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K904005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K904005: Huestis Flexi-Board.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904005
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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