510(k) · Cleared
ClearedAnzai Respiratory Gating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anzai Medical Co., Ltd. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Apr 22, 2016 as substantially equivalent to K031385 (Anzai Medical Co., Ltd., 2003) after a 66-day review. Its family tree reaches back 3 generations to 1987. 2 later devices descend from it.
- Decided
- Apr 22, 2016
- Review
- 66 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864886 (1987). 2 later devices descend from it, 1 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 backK031385 Anzai AZ-733 Respiratory Gating SystemAnzai Medical Co., Ltd. · 2003
- This deviceK160432 Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK170719 Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK243900 eMotus Respiratory Motion Management SystemEmpnia, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView 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 | K031385 | Anzai AZ-733 Respiratory Gating System | Anzai Medical Co., Ltd. | 2003 | — |
| 0 (this device) | K160432 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | 2016 | — |
| +1 | K170719 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | 2017 | — |
| +2 | K243900 | eMotus Respiratory Motion Management System | Empnia, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K031385 | Anzai AZ-733 Respiratory Gating SystemSummary page 5…32 3. Predicate Device AZ-733V Respiratory Gating System, K031385 4. Device Description The Respiratory Gating System AZ-733VI employs a respiratory sensor which can be fixed directly to or nea… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170719 | Anzai Respiratory Gating System | 2017 | 1 |
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 29 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K170719 (Anzai Medical Co., Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K031385.
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. 2016, this device’s year, is highlighted.
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 Respiratory Gating System AZ-733VI is intended to be used with diagnostic x-ray or radiation therapy systems to gate these devices on and off when target points of the patient's respiratory cycle are within preset limits.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160432: Anzai 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/K160432
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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