510(k) · Cleared
ClearedMaestro System (REF100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moon Surgical · FQO Table, Operating-Room, Ac-Powered
Cleared on Jun 3, 2024 as substantially equivalent to K221410 (Moon Surgical, 2022) after a 91-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Jun 3, 2024
- Review
- 91 days
- Class
- Class I
- Product code
- FQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K936308 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK936308 Endex Endoscopic Positioning SystemAndronic Devices, Ltd. · 1994
- 1 generation backK221410 Maestro PlatformMoon Surgical · 2022
- This deviceK240598 Maestro System (REF100)Moon Surgical · 2024
- Descendant · cites it directly · 1 of its ownK242323 Maestro System (REF100)Moon Surgical · 2025
- Descendant · 2 generations on · 0 of its ownK250984 Maestro System (REF100)Moon Surgical · 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 |
|---|---|---|---|---|---|
| −2 | K936308 | Endex Endoscopic Positioning System | Andronic Devices, Ltd. | 1994 | — |
| −1 | K221410 | Maestro Platform | Moon Surgical | 2022 | — |
| 0 (this device) | K240598 | Maestro System (REF100) | Moon Surgical | 2024 | — |
| +1 | K242323 | Maestro System (REF100) | Moon Surgical | 2025 | — |
| +2 | K250984 | Maestro System (REF100) | Moon Surgical | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 FQO? 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 FQO device
- #1 K221410 Maestro Platformscore 10.4 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K221410 | Maestro PlatformSummary page 4…Table, Operating-Room, AC-Powered Product Code/ Regulation: QZB 21 CFR 870.4960 Classification: Class I Predicate Device: Maestro System (K221410) Subject Device Description The Moon Maestro System is a 2-arm system which utilizes software and hardware to provide support to… | 2022 |
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 |
|---|---|---|---|
| K242323 | Maestro System (REF100) | 2025 | 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 30 years and passes through 2 companies; a new generation was cleared every 28.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K242323 (Moon Surgical, 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K221410.
How does its category compare?
All FQO devicesFQO Table, Operating-Room, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FQO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FQO
Too few FQO 510(k)s in any year since 2007 to give a median.
Recalls per year · FQO
8in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FQO
113in 2025
MAUDE reports naming product code FQO, 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 | 0 | — | 0 | 61 |
| 2008 | 0 | — | 10 | 47 |
| 2009 | 1 | — | 3 | 58 |
| 2010 | 0 | — | 3 | 127 |
| 2011 | 0 | — | 7 | 101 |
| 2012 | 0 | — | 0 | 120 |
| 2013 | 0 | — | 1 | 116 |
| 2014 | 0 | — | 1 | 145 |
| 2015 | 0 | — | 2 | 108 |
| 2016 | 0 | — | 2 | 93 |
| 2017 | 0 | — | 0 | 98 |
| 2018 | 0 | — | 5 | 104 |
| 2019 | 0 | — | 0 | 118 |
| 2020 | 0 | — | 2 | 97 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 1 | — | 1 | 125 |
| 2023 | 0 | — | 2 | 187 |
| 2024 | 1 | — | 8 | 139 |
| 2025 | 0 | — | 0 | 113 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240598: Maestro System (REF100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240598
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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