510(k) · Cleared
ClearedRespiratory Gating for Scanners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 13, 2015 as substantially equivalent to K102024 (Varian Medical Systems, 2010) after a 66-day review. Its family tree reaches back 4 generations to 1987. 3 later devices descend from it.
- Decided
- Aug 13, 2015
- Review
- 66 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K864886 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 3 generations backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- 2 generations backK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
- 1 generation backK102024 RPM Respiratory Gating SystemVarian Medical Systems · 2010 · Recalled
- This deviceK151533 Respiratory Gating for ScannersVarian Medical Systems, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK213927 Respiratory Gating for Scanners v2.0Varian Medical Systems, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK253026 Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK242874 Gating Reflector BlockVarian Medical Systems, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See all- K213927Respiratory Gating for Scanners v2.0Varian Medical Systems, Inc. · 2022 · cites it directly2descendants
- K253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc. · 2026 · 2 generations on0descendants
- K242874Gating Reflector BlockVarian Medical Systems, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −3 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| −2 | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | 1 |
| −1 | K102024 | RPM Respiratory Gating System | Varian Medical Systems | 2010 | 1 |
| 0 (this device) | K151533 | Respiratory Gating for Scanners | Varian Medical Systems, Inc. | 2015 | — |
| +1 | K213927 | Respiratory Gating for Scanners v2.0 | Varian Medical Systems, Inc. | 2022 | — |
| +2 | K253026 | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | 2026 | — |
| +2 | K242874 | Gating Reflector Block | Varian Medical Systems, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 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 |
|---|---|---|---|
| * | K102024 | RPM Respiratory Gating SystemSummary page 4…Product Code: JAK III. PREDICATE DEVICE Name of Predicate: RPM Respiratory Gating System 510(k) Number: K102024 Product: Respiratory Gating For Scanners Document: 510k Summary Section… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213927 | Respiratory Gating for Scanners v2.0 | 2022 | 2 |
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 28 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K213927 (Varian Medical Systems, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K102024.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
Respiratory Gating for Scanners (RGSC) is used to characterize the patient's respiratory patterns, providing the necessary information to diagnostic devices to acquire images synchronized with the breathing motion. RGSC can also be used to monitor the patient position during the image acquisition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151533: Respiratory Gating for Scanners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151533
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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