510(k) · Cleared
Recalled · Class II · 2013RPM Respiratory Gating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · IYE Accelerator, Linear, Medical
Cleared on Oct 15, 2010 as substantially equivalent to K063270 (Varian Medical Systems, Inc., 2006) after an 88-day review. Its family tree reaches back 3 generations to 1987. 6 later devices descend from it. It has been recalled once.
- Decided
- Oct 15, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864886 (1987). 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 2 generations backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- 1 generation backK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
- This deviceK102024 RPM Respiratory Gating SystemVarian Medical Systems · 2010
- Descendant · cites it directly · 3 of its ownK151533 Respiratory Gating for ScannersVarian Medical Systems, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK213927 Respiratory Gating for Scanners v2.0Varian Medical Systems, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK253026 Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK242874 Gating Reflector BlockVarian Medical Systems, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK121845 SDX SystemDyn'R Sas · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151533Respiratory Gating for ScannersVarian Medical Systems, Inc. · 2015 · cites it directly3descendants
- K213927Respiratory Gating for Scanners v2.0Varian Medical Systems, Inc. · 2022 · 2 generations on2descendants
- K253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc. · 2026 · 3 generations on0descendants
- K242874Gating Reflector BlockVarian Medical Systems, Inc. · 2024 · 3 generations on0descendants
- K121845SDX SystemDyn'R Sas · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −2 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| −1 | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | 1 |
| 0 (this device) | K102024 | RPM Respiratory Gating System | Varian Medical Systems | 2010 | — |
| +1 | K151533 | Respiratory Gating for Scanners | Varian Medical Systems, Inc. | 2015 | — |
| +2 | K213927 | Respiratory Gating for Scanners v2.0 | Varian Medical Systems, Inc. | 2022 | — |
| +3 | K253026 | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | 2026 | — |
| +3 | K242874 | Gating Reflector Block | Varian Medical Systems, Inc. | 2024 | — |
| +1 | K121845 | SDX System | Dyn'R Sas | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K063270 | RPM Respiratory Gating SystemSummary page 1…Product Code: IYE.LHN Common/Usual Name: RPM Respiratory Gating System Predicate Devices: RPM Respiratory Gating System (K063270) pevjce PescriptiQn; The Varian RPM Respiratory Gating is an attachment to radiation… | 2006 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2013 | Class II | Z-1163-2013 | Device Design | Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K151533 (Varian Medical Systems, Inc., 2015) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K063270.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 RPM Respiratory Gating System is used to obtain tracking of the subject respiratory pattern for respiratory synchronized image acquisition and radiation therapy treatment. It can also be used to monitor the patient position during image acquisition, simulation and treatment.
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/K102024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102024: RPM Respiratory Gating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102024
Report an extraction error
Are you the manufacturer?
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