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 · QZB Software Controlled Endoscope And Instrument Holder
Cleared on Jun 27, 2025 as substantially equivalent to K242323 (Moon Surgical, 2025) after an 88-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Jun 27, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- QZB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K931783 (1993). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 7 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 6 generations backK963126 Aesop System and AccessoriesComputer Motion, Inc. · 1997
- 5 generations backK972699 Aesop 3000 System and AccessoriesComputer Motion, Inc. · 1997
- 4 generations backK062968 Lapman Laparoscope Manipulator and Accessories, Model 900-200 SeriesMedsys, S.A. · 2007
- 3 generations backK131375 Autolap SystemMst - Medical Surgery Technologies, Ltd. · 2013
- 2 generations backK152848 Autolap SystemM.S.T Medical Surgery Technologies, Ltd. · 2015
- 1 generation backK242323 Maestro System (REF100)Moon Surgical · 2025
- This deviceK250984 Maestro System (REF100)Moon Surgical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −7 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −6 | K963126 | Aesop System and Accessories | Computer Motion, Inc. | 1997 | — |
| −5 | K972699 | Aesop 3000 System and Accessories | Computer Motion, Inc. | 1997 | — |
| −4 | K062968 | Lapman Laparoscope Manipulator and Accessories, Model 900-200 Series | Medsys, S.A. | 2007 | — |
| −3 | K131375 | Autolap System | Mst - Medical Surgery Technologies, Ltd. | 2013 | — |
| −2 | K152848 | Autolap System | M.S.T Medical Surgery Technologies, Ltd. | 2015 | — |
| −1 | K242323 | Maestro System (REF100) | Moon Surgical | 2025 | — |
| 0 (this device) | K250984 | Maestro System (REF100) | Moon Surgical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 QZB? 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 QZB device
- #1 K242323 Maestro System (REF100)score 13.8 · 7 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 |
|---|---|---|---|
| * | K242323 | Maestro System (REF100)Summary page 5…ion Name(s): Software Controlled Endoscope and Instrument Holder Product Code/ Regulation: QZB 21 CFR 876.1500 Classification: Class 2 Predicate Device: Maestro System (K242323) Maestro System Device Description The Moon Maestro System is a 2-arm system which utilizes software and hardware to provide sup… | 2025 |
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 32 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All QZB devicesQZB Software Controlled Endoscope And Instrument Holder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QZB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QZB
Too few QZB 510(k)s in any year since 2007 to give a median.
Recalls per year · QZB
No recall names QZB since 2007.
Adverse event reports per year · QZB
No MAUDE report names QZB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
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/K250984 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250984: 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/K250984
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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