510(k) · Cleared
ClearedRespiratory Gating for Scanners (2.1)
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 Jun 4, 2026 as substantially equivalent to K213927 (Varian Medical Systems, Inc., 2022) after a 258-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Jun 4, 2026
- Review
- 258 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K864886 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 5 generations backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- 4 generations backK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
- 3 generations backK102024 RPM Respiratory Gating SystemVarian Medical Systems · 2010 · Recalled
- 2 generations backK151533 Respiratory Gating for ScannersVarian Medical Systems, Inc. · 2015
- 1 generation backK213927 Respiratory Gating for Scanners v2.0Varian Medical Systems, Inc. · 2022
- This deviceK253026 Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −5 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| −4 | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | 1 |
| −3 | K102024 | RPM Respiratory Gating System | Varian Medical Systems | 2010 | 1 |
| −2 | K151533 | Respiratory Gating for Scanners | Varian Medical Systems, Inc. | 2015 | — |
| −1 | K213927 | Respiratory Gating for Scanners v2.0 | Varian Medical Systems, Inc. | 2022 | — |
| 0 (this device) | K253026 | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K213927 | Respiratory Gating for Scanners v2.0Summary page 5…Product Code: JAK Common name: System, X-Ray, Tomography, Computed III. Predicate Device Proprietary Name: Regulatory Gating for Scanners (2.0) (K213927) Regulation Number: 21 CFR §892.1750 Classification Name: Computed tomography x-ray system Product Cod… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K213927.
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. 2026, 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/K253026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253026: Respiratory Gating for Scanners (2.1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253026
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026