510(k) · Cleared
ClearedPelvis Bellyboard Plus Patient Positioning System
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 Apr 9, 2004 as substantially equivalent to K023293 (Med-Tec,Inc., 2002) and 6 other predicates after a 14-day review. Its family tree reaches back 1 generation to 1990. 9 later devices descend from it.
- Decided
- Apr 9, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 1 generation to K895697 (1990). 7 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK895697 Vac Fix (R) SystemS&S Par Scientific · 1990
- This deviceK040773 Pelvis Bellyboard Plus Patient Positioning SystemBionix Development Corp. · 2004
- Descendant · cites it directly · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK153026 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions · 2016
- Descendant · 3 generations on · 1 of its ownK210894 Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK132124 Klarity Vacuum Bag, Klarity Mold CushionKlarity Medical Products, LLC · 2013 · Recalled
- Descendant · 4 generations on · 0 of its ownK222762 Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · cites it directly5descendants
- K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions · 2016 · 2 generations on3descendants
- K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021 · 3 generations on1descendant
- K132124Klarity Vacuum Bag, Klarity Mold CushionKlarity Medical Products, LLC · 2013 · cites it directly1descendant
- K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895697 | Vac Fix (R) System | S&S Par Scientific | 1990 | — |
| 0 (this device) | K040773 | Pelvis Bellyboard Plus Patient Positioning System | Bionix Development Corp. | 2004 | — |
| +1 | K122888 | CDR Systems Precision Patient Positioning System | Cdr Systems, Inc. | 2013 | — |
| +2 | K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body… | Medtec, Inc. D/B/A Civco Medical Solutions | 2016 | — |
| +3 | K210894 | Siddharth-II; Impact | Panacea Medical Technologies Pvt., Ltd. | 2021 | — |
| +1 | K132124 | Klarity Vacuum Bag, Klarity Mold Cushion | Klarity Medical Products, LLC | 2013 | 1 |
| +4 | K222762 | Siddharth-II;Impact | Panacea Medical Technologies Pvt., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (8)
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 |
|---|---|---|---|
| * | K023293 | Med-Tec Bellyboard, Models MT-Bba-01 & MT-Bba-02Summary page 1…device has been classified as a Class II device by the FDA, and has been granted marketing clearance and has been assigned the document control number K023293. The Advanced Belly board System from Med-Tec consists of a thlermoformed plastic shell with a foam core. The… | 2002 |
| * | K935300 | Vac-Lok Immobilization SystemSummary page 5…This device has been classified as a Class II device by the FDA, and has been granted marketing clearance and has been assigned the document control number K935300. Another such device is the Vac Fix System manufactured and legally marketed by S&S Par Scientific of Great Neck,… | 1994 |
| * | K895697 | Vac Fix (R) SystemSummary page 5…This device has been classified as a Class II device by the FDA, and has been granted marketing clearance and has been assigned the document control number K895697. The Vac-Lok Immobilization System from Med-Tec consists of bags made from a nylon-reinforced blue urethane material… | 1990 |
| * | K951808 | Med-Tec Redi-FoamSummary page 8…This device has been classified as a Class II device by the FDA, and has been granted marketing clearance and has been assigned the document control number K951808. Another such device is Rapid-Foam manufactured and legally marketed by Soule, Inc. of Tampa, Florida. This device… | 1995 |
| * | K952457 | Rapid-FoamSummary page 8…This device has been classified as a Class II device by the FDA, and has been granted marketing clearance and has been assigned the document control number K952457. The Med-Tec RediFoam is a two-part foaming agent comprised of a part A (diisocyanate) and a part B (polyol). When… | 1995 |
| * | K973842 | Carbon Fiber Conformal Couch TopSummary page 11…is device has been classified as a Class II device by the FDA, and has been granted marketing clearance and has been assigned the document control number K973842. The Med-Tec Exact Lok-Bar provides a means to position a patient immobilization device such as a belly board on… | 1997 |
| * | K935412 | Med-Tec, Inc. Breast Board, MT-200Summary page 13…200 Acrylic Breastboard", manufactured and sold by Med-Tec, Inc. of Orange City, Iowa. The document control number for this product's 5 10(k) submission is K935412. The MT-200 Acrylic Breastboard from Med-Tec consists of two pieces of machined acrylic plastic hinged together to… | 1994 |
| * | — | AccuFix IMRT Quick-fix Carbon Fiber Pelvis System Named without a submission number |
What descends from it? (9)
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?
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 | — |
What is it indicated for?
The Bionix Pelvis BellyBoard PLUS patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning 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. The Bionix SecureVac patient positioning system developed…
Read the full statement (305 words)
The Bionix Pelvis BellyBoard PLUS patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning 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.
The Bionix SecureVac patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning 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.
The Bionix SecureFoam patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning 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.
The Bionix SecureFit Bar patient positioning device developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning 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.
The Bionix Extended Butterfly Armboard patient positioning device, developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning 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/K040773 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040773: Pelvis Bellyboard Plus Patient Positioning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040773
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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