510(k) · Cleared
ClearedConmed Integrated Systems Nurses Assistant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Integrated Systems (Cmis) · FSY Light, Surgical, Ceiling Mounted
Cleared on Jul 25, 2003 as substantially equivalent to K010754 (Valmed Corp., 2001) and 2 other predicates after a 29-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Jul 25, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K931783 (1993). 34 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet.
- Root · 6 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 5 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 4 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 3 generations backK023095 Hermes Operating Room Control CenterComputer Motion, Inc. · 2002
- 2 generations backK024294 Modification to Hermes Operating Room Control CenterComputer Motion, Inc. · 2003
- 1 generation backK030240 Modification to Hermes Operating Room Control CenterComputer Motion, Inc. · 2003
- This deviceK031979 Conmed Integrated Systems Nurses AssistantConmed Integrated Systems (Cmis) · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −5 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −4 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −3 | K023095 | Hermes Operating Room Control Center | Computer Motion, Inc. | 2002 | — |
| −2 | K024294 | Modification to Hermes Operating Room Control Center | Computer Motion, Inc. | 2003 | — |
| −1 | K030240 | Modification to Hermes Operating Room Control Center | Computer Motion, Inc. | 2003 | — |
| 0 (this device) | K031979 | Conmed Integrated Systems Nurses Assistant | Conmed Integrated Systems (Cmis) | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 FSY? 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? (3)
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 |
|---|---|---|---|
| * | K010754 | Nurse's Assistant O.R. Control SystemSummary page 5…ant® O.R. Control System Page 2 4) Predicate Devices This device is substantially equivalent to the ConMed Integrated Systems’ Nurse’s Assistant® O.R. Control System (K010754), Modification to Olympus' Integrated Endosurgery System EndoALPHA (K022270). and Modification to Computer Motion’s HERMES Operat… | 2001 |
| * | K022270 | Modification to Olympus Integrated Endosurgery System EndoalphaSummary page 5…antially equivalent to the ConMed Integrated Systems’ Nurse’s Assistant® O.R. Control System (K010754), Modification to Olympus' Integrated Endosurgery System EndoALPHA (K022270). and Modification to Computer Motion’s HERMES Operatir.g Room Control Center (K030240). 5) Device Description The Nurse's Assi… | 2002 |
| * | K030240 | Modification to Hermes Operating Room Control CenterSummary page 5…ystem (K010754), Modification to Olympus' Integrated Endosurgery System EndoALPHA (K022270). and Modification to Computer Motion’s HERMES Operatir.g Room Control Center (K030240). 5) Device Description The Nurse's Assistant® is a programmable controller operated through a touch screen GUI that offers pro… | 2003 |
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 10 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 34 ancestors has a recall.
- 2 other devices also cite its predicate K010754.
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FSY
7in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FSY
59in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FSY
11in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FSY
286in 2025
MAUDE reports naming product code FSY, 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 | 3 | 29 | 0 | 70 |
| 2008 | 2 | — | 0 | 53 |
| 2009 | 2 | — | 4 | 40 |
| 2010 | 5 | 130 | 3 | 72 |
| 2011 | 0 | — | 4 | 70 |
| 2012 | 2 | — | 4 | 171 |
| 2013 | 3 | 118 | 1 | 137 |
| 2014 | 7 | 59 | 0 | 139 |
| 2015 | 0 | — | 228 | 175 |
| 2016 | 0 | — | 0 | 182 |
| 2017 | 0 | — | 0 | 162 |
| 2018 | 0 | — | 2 | 316 |
| 2019 | 0 | — | 4 | 444 |
| 2020 | 0 | — | 0 | 439 |
| 2021 | 0 | — | 0 | 380 |
| 2022 | 0 | — | 0 | 430 |
| 2023 | 0 | — | 11 | 663 |
| 2024 | 0 | — | 0 | 541 |
| 2025 | 0 | — | 0 | 286 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The Nurse's Assistant® is a programmable controlier operated through a touch screen GUI that offers professional O.R. staff a simplified remote user interface and a real time display of settings for the devices attached to the system thereby eliminating the necessity for using the various control panels on diverse surgical equipment. The Nurse's Assistant®is intended to be used to tum on and off, and adjust certain settings of, endoscopic and surgical…
Read the full statement (225 words)
The Nurse's Assistant® is a programmable controlier operated through a
touch screen GUI that offers professional O.R. staff a simplified remote user
interface and a real time display of settings for the devices attached to the
system thereby eliminating the necessity for using the various control panels on
diverse surgical equipment.
The Nurse's Assistant®is intended to be used to tum on and off, and
adjust certain settings of, endoscopic and surgical cameras. electrosurgical
generators such as the ConMed System 5000 ESU, laparoscopic insufflators
such as the Linvatec GS1002 insufflator, surgical lamps, operating room (“O.R.")
lights, and operate digital documentation products, VCR's, video monitors, video
printers, radios and CD players.
The Nurse's Assistant®is indicated for use in general, cardiovascular,
ENT, gastroenterology, urology, plastic, obstetrics, gynecolcgy, and orthopedic
surgery, and general thorascoscopy, general cardiothoracic surgery, general
laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy. A few
examples of the more common surgical procedures where this system could be
used are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic
appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically
assisted hysterectomy, laparoscopic and thorascopic anteriorspinal fusion,
decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal
sympathectomy, pleurodesis, intemal mammary artery dissection for coronary
artery bypass, coronary artery bypass grafting where endoscopic visualization is
indicated, examination of the evacuated cardiac chamber during performance of
valve replacement, arthroscopic meniscus repair, anterior cruciate ligament
repair and associated procedures.
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/K031979 · printed Nov 3, 2026
Cite this page
510(k) Report. “K031979: Conmed Integrated Systems Nurses Assistant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K031979
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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