510(k) · Cleared
ClearedNurse's Assistant 1.7 O.R. Control System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Integrated Systems (Cmis) · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 6, 2005 as substantially equivalent to K010754 (Valmed Corp., 2001) and 2 other predicates after a 35-day review. Its family tree reaches back 4 generations to 1980. 3 later devices descend from it.
- Decided
- May 6, 2005
- Review
- 35 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K801623 (1980). 26 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 3 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 2 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 1 generation backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- This deviceK050829 Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005
- Descendant · cites it directly · 2 of its ownK052740 Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005
- Descendant · cites it directly · 1 of its ownK060717 Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006
- Descendant · 2 generations on · 0 of its ownK091648 Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis) · 2009
Most influential descendants
Showing 3 of 3 · See all- K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005 · cites it directly2descendants
- K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006 · cites it directly1descendant
- K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis) · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −3 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −2 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −1 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| 0 (this device) | K050829 | Nurse's Assistant 1.7 O.R. Control System | Conmed Integrated Systems (Cmis) | 2005 | — |
| +1 | K052740 | Nurse's Assistant 1.7 O.R. Control System | Conmed Integrated Systems (Cmis) | 2005 | — |
| +1 | K060717 | Nurse Assistant 1.7 O.R. Control System | Conmed Integrated Systems (Cmis) | 2006 | — |
| +2 | K091648 | Nurse's Assistant O.R. Control System ,1.8 | Conmed Integrated Systems (Cmis) | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 8 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 1…I Product Codes: GCJ, KOG, FET, FSY, HET, FTA D. Predicate/Legally Marketed Devices: 1. Val Med Nurse's Assistant O.R. Control System- K010754 2. Olympus Integrated Endosurgery System EndoALPHA - K981993 3. Karl Storz OR1 (KSEA SCB-ACC) - K023704 === Page… | 2001 |
| * | K981993 | Olympus Integrated Endosurgery System EndoalphaSummary page 1…D. Predicate/Legally Marketed Devices: 1. Val Med Nurse's Assistant O.R. Control System- K010754 2. Olympus Integrated Endosurgery System EndoALPHA - K981993 3. Karl Storz OR1 (KSEA SCB-ACC) - K023704 E. Device Description: The Nurse's Assistant® 1.7 O.R.… | 1998 |
| * | K023704 | Ksea SCB Acc ControlSummary page 1…1. Val Med Nurse's Assistant O.R. Control System- K010754 2. Olympus Integrated Endosurgery System EndoALPHA - K981993 3. Karl Storz OR1 (KSEA SCB-ACC) - K023704 E. Device Description: The Nurse's Assistant® 1.7 O.R. Control System is a computerized control syste… | 2003 |
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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 26 ancestors has a recall.
- Of its descendants, K052740 (Conmed Integrated Systems (Cmis), 2005) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K010754.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The Nurse's Assistant® 1.7 is intended to be used to route video from multiple sources to multiple destinations, to be used to turn on and off power to specific 110 volt receptacles within the OR, and to be used to adjust specific operating parameters of video displays, analog or digital recording, communication and playback equipment, endoscopic cameras, endoscopic light sources, surgical lamps, observation cameras, surgical cameras and operating room…
Read the full statement (141 words)
The Nurse's Assistant® 1.7 is intended to be used to route video from multiple sources to multiple destinations, to be used to turn on and off power to specific 110 volt receptacles within the OR, and to be used to adjust specific operating parameters of video displays, analog or digital recording, communication and playback equipment, endoscopic cameras, endoscopic light sources, surgical lamps, observation cameras, surgical cameras and operating room lights.
The Nurse's Assistant® 1.7 is indicated for use in an operating room for video assisted surgery. This includes minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques and traditional open procedures.
The Nurse's Assistant® 1.7 is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharyngoscopy, ear endoscopy and sinusoscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050829: Nurse's Assistant 1.7 O.R. Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050829
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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