510(k) · Cleared
ClearedNurse's Assistant O.R. Control System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valmed Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 15, 2001 after a 155-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Aug 15, 2001
- Review
- 155 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK010754 Nurse's Assistant O.R. Control SystemValmed Corp. · 2001
- Descendant · cites it directly · 8 of its ownK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · Recalled
- Descendant · cites it directly · 3 of its ownK050829 Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005
- Descendant · 2 generations on · 2 of its ownK100852 Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010
- Descendant · 2 generations on · 2 of its ownK070556 Brainsuite NetBrainlab AG · 2007
- Descendant · 2 generations on · 2 of its ownK052740 Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K033132Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · cites it directly8descendants
- K050829Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005 · cites it directly3descendants
- K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010 · 2 generations on2descendants
- K070556Brainsuite NetBrainlab AG · 2007 · 2 generations on2descendants
- K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010754 | Nurse's Assistant O.R. Control System | Valmed Corp. | 2001 | — |
| +1 | K033132 | Stryker Switchpoint Infinity | Stryker Communications Corp. | 2004 | 11 |
| +1 | K050829 | Nurse's Assistant 1.7 O.R. Control System | Conmed Integrated Systems (Cmis) | 2005 | — |
| +2 | K100852 | Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000 | Stryker Communications | 2010 | — |
| +2 | K070556 | Brainsuite Net | Brainlab AG | 2007 | — |
| +2 | K052740 | Nurse's Assistant 1.7 O.R. Control System | Conmed Integrated Systems (Cmis) | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 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? (6)
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 |
|---|---|---|---|
| * | — | Computer Motion’s Hermes Operating Room Control Center Named without a submission number | |
| * | — | Olympus EndoAlpha Named without a submission number | |
| * | — | Karl Storz KSEA SCB-RUI Named without a submission number | |
| * | — | Hill-Rom, Inc.’s BrightStar© Named without a submission number | |
| * | — | American Sterilizer Co.’s Quantum®, SQ24 Named without a submission number | |
| * | — | Getinge/Castle, Inc. OptiView©, 500 series Named without a submission number |
What descends from it? (12)
See all 123 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?
- Of its descendants, K033132 (Stryker Communications Corp., 2004) has gone furthest, with 8 descendants of its own.
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 is intended to be used to turn on and off and adjust certain settings of endoscopic and surgical cameras, surgical lamps, and operating room ("O.R." lights, and to operate VCRs, monitors, video printers, radios, and CD players. The Val Med Nurse's Assistant is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thorascoscopy, general…
Read the full statement (159 words)
The Nurse's Assistant is intended to be used to turn on and off and adjust certain settings of endoscopic and surgical cameras, surgical lamps, and operating room ("O.R." lights, and to operate VCRs, monitors, video printers, radios, and CD players.
The Val Med Nurse's Assistant is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, 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, internal 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/K010754 · printed Nov 3, 2026
Cite this page
510(k) Report. “K010754: Nurse's Assistant O.R. Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K010754
Report an extraction error
Are you the manufacturer?
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