510(k) · Cleared
ClearedBody Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtec, Inc. D/B/A Civco Medical Solutions · IYE Accelerator, Linear, Medical
Cleared on May 25, 2016 as substantially equivalent to K122888 (Cdr Systems, Inc., 2013) after a 222-day review. Its family tree reaches back 6 generations to 1994. 3 later devices descend from it.
- Decided
- May 25, 2016
- Review
- 222 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K935300 (1994). 34 ancestors in all, the oldest K854886 (1986). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK935300 Vac-Lok Immobilization SystemMedtec, Inc. · 1994
- 5 generations backK960338 Stereotactic Body FrameElekta Instrument AB · 1996
- 4 generations backK970291 Accessories to the Stereotactic Body FramElekta Instrument AB · 1997
- 3 generations backK991336 Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco) · 1999
- 2 generations backK100691 Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp. · 2010
- 1 generation backK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
- This deviceK153026 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions · 2016
- Descendant · cites it directly · 1 of its ownK210894 Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK222762 Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK171133 Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution…Qfix · 2017
Most influential descendants
Showing 3 of 3 · See all- K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021 · cites it directly1descendant
- K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023 · 2 generations on0descendants
- K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesQfix · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935300 | Vac-Lok Immobilization System | Medtec, Inc. | 1994 | — |
| −5 | K960338 | Stereotactic Body Frame | Elekta Instrument AB | 1996 | — |
| −4 | K970291 | Accessories to the Stereotactic Body Fram | Elekta Instrument AB | 1997 | — |
| −3 | K991336 | Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy | Medical Instrumentation & Diagnostics Corp.(Midco) | 1999 | — |
| −2 | K100691 | Omni V SBRT Positioning System, Model RT-4500 | Bionix Development Corp. | 2010 | — |
| −1 | K122888 | CDR Systems Precision Patient Positioning System | Cdr Systems, Inc. | 2013 | — |
| 0 (this device) | K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body… | Medtec, Inc. D/B/A Civco Medical Solutions | 2016 | — |
| +1 | K210894 | Siddharth-II; Impact | Panacea Medical Technologies Pvt., Ltd. | 2021 | — |
| +2 | K222762 | Siddharth-II;Impact | Panacea Medical Technologies Pvt., Ltd. | 2023 | — |
| +1 | K171133 | Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and… | Qfix | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K122888 | CDR Systems Precision Patient Positioning SystemSummary page 4…Manufacturer Compression Bridge and Compression Belt included in CDR Systems CDR Systems, Inc. Precision Patient Positioning System (K122888) The purpose of this 510(k) is to 1) modify the design of the Respiratory Plate by attaching an inflatable Cushion, 2)… | 2013 |
What descends from it? (3)
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 22 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 34 ancestors have a recall of any class.
- Of its descendants, K210894 (Panacea Medical Technologies Pvt., Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K122888.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 device is indicated to assist in the proper positioning of patients for radiation therapy including electron, photon and proton treatments, and simulation including CT and MR image acquisition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153026
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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