510(k) · Cleared
ClearedRPM Respiratory Gating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jun 8, 1999 as substantially equivalent to K864886 (Nims/Respitrace Corp., 1987) after a 236-day review. Its family tree reaches back 1 generation to 1987. 108 later devices descend from it.
- Decided
- Jun 8, 1999
- Review
- 236 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K864886 (1987). 108 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- This deviceK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- Descendant · cites it directly · 83 of its ownK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 43 of its ownK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 37 of its ownK123291 TruebeamVarian Medical Systems, Inc. · 2012
- Descendant · cites it directly · 36 of its ownK123808 AgilityElekta, Ltd. · 2013 · Recalled
Showing 5 of 108 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 108 · See all- K063270RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · cites it directly83descendants
- K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · 2 generations on61descendants
- K111106TruebeamVarian Medical Systems, Inc. · 2011 · 3 generations on43descendants
- K123291TruebeamVarian Medical Systems, Inc. · 2012 · 4 generations on37descendants
- K123808AgilityElekta, Ltd. · 2013 · cites it directly36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| 0 (this device) | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| +1 | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | 1 |
| +2 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| +3 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| +4 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| +1 | K123808 | Agility | Elekta, Ltd. | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 10 | 0 |
| 2022 | 6 | 0 |
| 2023 | 10 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 9 | 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 LHN? 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 LHN device
- #1 K260597 Virtue QAscore 15.4 · 12 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 |
|---|---|---|---|
| * | K864886 | Respigraph-Respisomnograph-RespicentralSummary page 1…s.varian.com Device Name: RPM Respiratory Gating System Classification Name: Radiographic ECG/Respirator Synchronizer, 901XO Predicate Device: NIMS Respitrace System, K864886 Product Description: The video-based RPM Respiratory Gating System provides a respiration gating signal to a Clinac radiation t… | 1987 |
What descends from it? (108)
See all 1087 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?
- Its one ancestor has no recall.
- Of its descendants, K063270 (Varian Medical Systems, Inc., 2006) has gone furthest, with 83 descendants of its own.
How does its category compare?
All LHN devicesLHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
MAUDE reports naming product code LHN, 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 | 2 | — | 2 | 0 |
| 2008 | 3 | 113 | 2 | 1 |
| 2009 | 5 | 69 | 0 | 5 |
| 2010 | 4 | 96 | 0 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 111 | 0 | 1 |
| 2013 | 3 | 70 | 0 | 1 |
| 2014 | 4 | 93 | 2 | 5 |
| 2015 | 3 | 53 | 1 | 2 |
| 2016 | 7 | 120 | 0 | 1 |
| 2017 | 4 | 173 | 5 | 7 |
| 2018 | 3 | 78 | 2 | 8 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 4 | 74 | 1 | 20 |
| 2021 | 0 | — | 1 | 24 |
| 2022 | 2 | — | 2 | 10 |
| 2023 | 2 | — | 1 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 3 | 190 | 0 | 11 |
| 2026 | 4 | 194 | 0 | — |
What is it indicated for?
The Varian RPM Respiratory Gating device is an attachment to the radiation therapy simulator and Varian Clinac radiation therapy treatment system. It is to be used to characterize (in simulation) the patient’s respiratory patterns and then, in treatment, to trigger beam-hold and limit the beam-on time to those points in the respiratory cycle where the target volume is within acceptable motion limits.
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/K983629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983629: 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/K983629
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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