510(k) · Cleared
ClearedSoloassist II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aktormed GmbH · NAY System, Surgical, Computer Controlled Instrument
Cleared on Sep 21, 2018 as substantially equivalent to K972699 (Computer Motion, Inc., 1997) after a 449-day review. Its family tree reaches back 4 generations to 1993. 4 later devices descend from it.
- Decided
- Sep 21, 2018
- Review
- 449 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K931783 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 3 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 2 generations backK963126 Aesop System and AccessoriesComputer Motion, Inc. · 1997
- 1 generation backK972699 Aesop 3000 System and AccessoriesComputer Motion, Inc. · 1997
- This deviceK171947 Soloassist IIAktormed GmbH · 2018
- Descendant · cites it directly · 2 of its ownK200473 SoloAsisst II, Voice ControlAktormed GmbH · 2020
- Descendant · 2 generations on · 1 of its ownK233312 SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426)…Aktormed GmbH · 2024
- Descendant · 3 generations on · 0 of its ownK261573 Endoscope Holder (182214)Aktormed GmbH · 2026
- Descendant · cites it directly · 0 of its ownK223673 Surgeon Controlled ArmLevita Magnetics International Corp · 2023
Most influential descendants
Showing 4 of 4 · See all- K200473SoloAsisst II, Voice ControlAktormed GmbH · 2020 · cites it directly2descendants
- K233312SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice…Aktormed GmbH · 2024 · 2 generations on1descendant
- K261573Endoscope Holder (182214)Aktormed GmbH · 2026 · 3 generations on0descendants
- K223673Surgeon Controlled ArmLevita Magnetics International Corp · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −3 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −2 | K963126 | Aesop System and Accessories | Computer Motion, Inc. | 1997 | — |
| −1 | K972699 | Aesop 3000 System and Accessories | Computer Motion, Inc. | 1997 | — |
| 0 (this device) | K171947 | Soloassist II | Aktormed GmbH | 2018 | — |
| +1 | K200473 | SoloAsisst II, Voice Control | Aktormed GmbH | 2020 | — |
| +2 | K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip… | Aktormed GmbH | 2024 | — |
| +3 | K261573 | Endoscope Holder (182214) | Aktormed GmbH | 2026 | — |
| +1 | K223673 | Surgeon Controlled Arm | Levita Magnetics International Corp | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 NAY? 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 NAY device
- #1 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 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 |
|---|---|---|---|
| * | K972699 | Aesop 3000 System and AccessoriesSummary page 5…Class II (i.e., whether it is unclassified or a class I, II, or III device) Predicate Device 510(k) Number K972699 5. Description of the Device Device Identification: Key device: - Soloassist II Device compon… | 1997 |
What descends from it? (4)
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?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K200473 (Aktormed GmbH, 2020) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K972699.
How does its category compare?
All NAY devicesNAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NAY
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NAY
117in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NAY
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NAY
48,456in 2025
MAUDE reports naming product code NAY, 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 | — | 11 | 133 |
| 2008 | 4 | 189 | 3 | 224 |
| 2009 | 3 | 253 | 1 | 380 |
| 2010 | 1 | — | 0 | 623 |
| 2011 | 7 | 191 | 2 | 501 |
| 2012 | 4 | 106 | 1 | 1,552 |
| 2013 | 4 | 144 | 6 | 6,217 |
| 2014 | 9 | 143 | 25 | 6,135 |
| 2015 | 3 | 99 | 3 | 1,722 |
| 2016 | 8 | 197 | 1 | 1,077 |
| 2017 | 16 | 107 | 1 | 1,049 |
| 2018 | 15 | 152 | 2 | 1,074 |
| 2019 | 8 | 73 | 5 | 1,154 |
| 2020 | 9 | 212 | 0 | 1,558 |
| 2021 | 11 | 61 | 3 | 1,997 |
| 2022 | 6 | 57 | 3 | 5,727 |
| 2023 | 5 | 141 | 2 (1) | 10,898 |
| 2024 | 10 | 126 | 40 | 12,872 |
| 2025 | 16 | 117 | 1 | 48,456 |
| 2026 | 7 | 89 | 4 (1) | — |
What is it indicated for?
The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection…
Read the full statement (126 words)
The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.
The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171947: Soloassist II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171947
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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