510(k) · Cleared
ClearedNurse's Assistant O.R. Control System ,1.8
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 Aug 5, 2009 as substantially equivalent to K060717 (Conmed Integrated Systems (Cmis), 2006) and 2 other predicates after a 57-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Aug 5, 2009
- Review
- 57 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K931783 (1993). 46 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet.
- Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 5 generations between
- 3 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 2 generations backK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · Recalled
- 1 generation backK060717 Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006
- This deviceK091648 Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis) · 2009
Show all 9 generations
- Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 8 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 7 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 6 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 5 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 4 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 3 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 2 generations backK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · Recalled
- 1 generation backK060717 Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006
- This deviceK091648 Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis) · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −8 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −7 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −6 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −5 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −4 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −3 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| −2 | K033132 | Stryker Switchpoint Infinity | Stryker Communications Corp. | 2004 | 11 |
| −1 | K060717 | Nurse Assistant 1.7 O.R. Control System | Conmed Integrated Systems (Cmis) | 2006 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 | 4 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K060717 | Nurse Assistant 1.7 O.R. Control SystemSummary page 4…Proposed Class/Device: Class il Product Codes: GCJ, KOG Predicate/Legally Marketed Devices: 1. ConMed Integrated Systems Nurse’s Assistant® 1.7 O.R. Control System — K060717 2. Stryker SwitchPoint Infinity System — K033132 3. Karl Storz OR1 SCB Interface Controf — K070827 1815 NW 169th Place, Suite… | 2006 |
| * | K033132 | Stryker Switchpoint InfinitySummary page 4…CJ, KOG Predicate/Legally Marketed Devices: 1. ConMed Integrated Systems Nurse’s Assistant® 1.7 O.R. Control System — K060717 2. Stryker SwitchPoint Infinity System — K033132 3. Karl Storz OR1 SCB Interface Controf — K070827 1815 NW 169th Place, Suite 4020 » Beaverion, C)ragon 97006 o TEL: {503} 614-1… | 2004 |
| * | K070827 | Karl Storz SCB Interface Control, Model 20090120Summary page 4…nMed Integrated Systems Nurse’s Assistant® 1.7 O.R. Control System — K060717 2. Stryker SwitchPoint Infinity System — K033132 3. Karl Storz OR1 SCB Interface Controf — K070827 1815 NW 169th Place, Suite 4020 » Beaverion, C)ragon 97006 o TEL: {503} 614-1106 = FAX: (503} 614-1109 » www.conmedis.com 5-1… | 2007 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 46 ancestors has a recall of any class.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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® O.R. Control System, 1.8 is a programmable electrical medical system that is intended to provide trained staff with a centralized user interface from which to route audio and video signals, and to perform auxiliary control functions for activating, adjusting and monitoring certain settings of compatible medical and non-medical equipment. The Nurse's Assistant® O.R. Control System, 1.8 is indicated for use in an operating room for…
Read the full statement (102 words)
The Nurse's Assistant® O.R. Control System, 1.8 is a programmable electrical medical system that is intended to provide trained staff with a centralized user interface from which to route audio and video signals, and to perform auxiliary control functions for activating, adjusting and monitoring certain settings of compatible medical and non-medical equipment.
The Nurse's Assistant® O.R. Control System, 1.8 is indicated for use in an operating room for video assisted surgery during minimally invasive and traditional open procedures in all surgical specialties. The System is also used as an adjunct display of interventional techniques and provides teleconferencing capability through an optional interface.
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/K091648 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091648: Nurse's Assistant O.R. Control System ,1.8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091648
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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