510(k) · Cleared
Recalled · 2007RPM Respiratory Gating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Dec 14, 2006 as substantially equivalent to K983629 (Varian Medical Systems, Inc., 1999) after a 45-day review. Its family tree reaches back 2 generations to 1987. 83 later devices descend from it. It has been recalled once.
- Decided
- Dec 14, 2006
- Review
- 45 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864886 (1987). 83 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 1 generation backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- This deviceK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006
- Descendant · cites it directly · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 43 of its ownK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 37 of its ownK123291 TruebeamVarian Medical Systems, Inc. · 2012
- Descendant · 3 generations on · 36 of its ownK123808 AgilityElekta, Ltd. · 2013 · Recalled
- Descendant · 4 generations on · 31 of its ownK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · cites it directly61descendants
- K111106TruebeamVarian Medical Systems, Inc. · 2011 · 2 generations on43descendants
- K123291TruebeamVarian Medical Systems, Inc. · 2012 · 3 generations on37descendants
- K123808AgilityElekta, Ltd. · 2013 · 3 generations on36descendants
- K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −1 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| 0 (this device) | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | — |
| +1 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| +2 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| +3 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| +3 | K123808 | Agility | Elekta, Ltd. | 2013 | 2 |
| +4 | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 9 | 0 |
| 2022 | 5 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K983629 | RPM Respiratory Gating SystemSummary page 1…tion therapy system. 21 CFR §892.5050 PrTodct Code: lYE 3. Predicate Device: RPM Respiratory Gating K983629 4. Description of the Device: The Varian RPM Respiratory Gating Device is an attachment to the Varian Clinac radiation therapy t… | 1999 |
What descends from it? (83)
See all 834 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 |
|---|---|---|---|---|
| Sep 26, 2007 | Not classified | Z-0554-2008 | Software design | Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets the phase-based gating thresholds to system default… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 12.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K092871 (Varian Medical Systems, Inc., 2009) has gone furthest, with 61 descendants of its own.
- 6 other devices also cite its predicate K983629.
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 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 be also used to monitor the patient position during the image acquisition, simulation and treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063270 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063270: RPM Respiratory Gating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063270
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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