510(k) · Cleared
ClearedMaestro Platform
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 Dec 2, 2022 as substantially equivalent to K936308 (Andronic Devices, Ltd., 1994) after a 200-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Dec 2, 2022
- Review
- 200 days
- Class
- Class I
- Product code
- FQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K936308 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK936308 Endex Endoscopic Positioning SystemAndronic Devices, Ltd. · 1994
- This deviceK221410 Maestro PlatformMoon Surgical · 2022
- Descendant · cites it directly · 2 of its ownK240598 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K936308 | Endex Endoscopic Positioning System | Andronic Devices, Ltd. | 1994 | — |
| 0 (this device) | K221410 | Maestro Platform | Moon Surgical | 2022 | — |
| +1 | 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 |
|---|---|---|
| 2024 | 1 | 0 |
| 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 K240598 Maestro System (REF100)score 10.7 · 2 generations · 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 |
|---|---|---|---|
| * | K936308 | Endex Endoscopic Positioning SystemSummary page 4…perating-Room, AC-Powered Product Code/ Regulation: FQO 21 CFR 878.4960 Classification: Class I Predicate Device: ENDEX Endoscopic Positioning System (K936308) Subject Device Description The Moon Maestro System utilizes software and hardware to provide support to surgeons for manipulati… | 1994 |
What descends from it? (3)
2 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, K240598 (Moon Surgical, 2024) has gone furthest, with 2 descendants of its own.
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. 2022, 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/K221410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221410: Maestro Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221410
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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