510(k) · Cleared
ClearedSocrates Robotic Telemonitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computer Motion, Inc. · NEQ Device, Telemedicine, Robotic
Cleared on Dec 10, 2001 as substantially equivalent to K003661 (Computer Motion, Inc., 2001) after a 25-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Dec 10, 2001
- Review
- 25 days
- Class
- Class II
- Product code
- NEQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003661 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003661 Socrates Robotic Telemonitoring SystemComputer Motion, Inc. · 2001
- This deviceK013804 Socrates Robotic Telemonitoring SystemComputer Motion, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003661 | Socrates Robotic Telemonitoring System | Computer Motion, Inc. | 2001 | — |
| 0 (this device) | K013804 | Socrates Robotic Telemonitoring System | Computer Motion, Inc. | 2001 | — |
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 NEQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K003661 | Socrates Robotic Telemonitoring SystemSummary page 1…in General and Plastic Surgery, Regulation Number 876.1500, Class I1. 3) Substantially equivalent to the Computer Motion, Inc. Socrates Robotic Telemonitoring System (K003661) 4) The SOCRATES System is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasop… | 2001 |
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?
- Its one ancestor has no recall.
How does its category compare?
All NEQ devicesNEQ Device, Telemedicine, Robotic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NEQ
FDA has decided no NEQ device since 2007.
Median 510(k) review, days · NEQ
Too few NEQ 510(k)s in any year since 2007 to give a median.
Recalls per year · NEQ
No recall names NEQ since 2007.
Adverse event reports per year · NEQ
No MAUDE report names NEQ 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 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SOCRATES System is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, €ar endoscopy, and sinuscopy where a rigid laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy…
Read the full statement (155 words)
The SOCRATES System is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, €ar endoscopy, and sinuscopy where a rigid laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafiing where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. Use of the SOCRATES System enables a remote surgeon [0 telecommunicate with any AESOP HR Jocal controller through HERMES. This communication link allows the remote surgeon 1o assist the local surgeon with field-of-view positioning.
The users of the SOCRATES System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons 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/K013804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013804: Socrates Robotic Telemonitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013804
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026