510(k) Report

510(k) · Cleared

Cleared

Modification to Hermes Operating Room Control Center

K030240510(k) SpecialCleared Feb 21, 200329-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Computer Motion, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Feb 21, 2003 as substantially equivalent to K973700 (Computer Motion, Inc., 1998) and 1 other predicate after a 29-day review. Its family tree reaches back 5 generations to 1993. 7 later devices descend from it.

Decided
Feb 21, 2003
Review
29 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K931783 (1993). 7 ancestors in all. 7 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor2000: 1 other ancestor2003: 4 descendants cleared2005: 1 descendant cleared2006: 1 descendant cleared2009: 1 descendant clearedK931783 · Aesop (Automated Endoscopic System for Optimal Pos · Computer Motion, Inc. · 1993K960655 · Aesop System and Accessories · Computer Motion, Inc. · 1996K973700 · Hermes Operating Room Control Center · Computer Motion, Inc. · 1998×2: 2 generations cleared close together, K023095 (2002), K024294 (2003) 1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K024294 · Modification to Hermes Operating Room Control Center · Computer Motion, Inc. · 2003K023095 · Hermes Operating Room Control Center · Computer Motion, Inc. · 2002K973700 · Hermes Operating Room Control Center · Computer Motion, Inc. · 1998K960655 · Aesop System and Accessories · Computer Motion, Inc. · 1996K931783 · Aesop (Automated Endoscopic System for Optimal Pos · Computer Motion, Inc. · 1993−50
  1. Root · 5 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
  2. 4 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
  3. 3 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
  4. 2 generations backK023095 Hermes Operating Room Control CenterComputer Motion, Inc. · 2002
  5. 1 generation backK024294 Modification to Hermes Operating Room Control CenterComputer Motion, Inc. · 2003
  6. This deviceK030240 Modification to Hermes Operating Room Control CenterComputer Motion, Inc. · 2003
  7. Descendant · cites it directly · 2 of its ownK052740 Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005
  8. Descendant · 2 generations on · 1 of its ownK060717 Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006
  9. Descendant · 3 generations on · 0 of its ownK091648 Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis) · 2009
  10. Descendant · cites it directly · 0 of its ownK031979 Conmed Integrated Systems Nurses AssistantConmed Integrated Systems (Cmis) · 2003
  11. Descendant · cites it directly · 0 of its ownK031956 Modification to Hermes O.R. Control CenterComputer Motion, Inc. · 2003

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003: 42005: 12006: 12009: 1
2003high 4 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · 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 · 2 generations on1descendant
  • K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis) · 2009 · 3 generations on0descendants
  • K031979Conmed Integrated Systems Nurses AssistantConmed Integrated Systems (Cmis) · 2003 · cites it directly0descendants
  • K031956Modification to Hermes O.R. Control CenterComputer Motion, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K931783Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc.1993—
−4K960655Aesop System and AccessoriesComputer Motion, Inc.1996—
−3K973700Hermes Operating Room Control CenterComputer Motion, Inc.1998—
−2K023095Hermes Operating Room Control CenterComputer Motion, Inc.2002—
−1K024294Modification to Hermes Operating Room Control CenterComputer Motion, Inc.2003—
0 (this device)K030240Modification to Hermes Operating Room Control CenterComputer Motion, Inc.2003—
+1K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)2005—
+2K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)2006—
+3K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis)2009—
+1K031979Conmed Integrated Systems Nurses AssistantConmed Integrated Systems (Cmis)2003—
+1K031956Modification to Hermes O.R. Control CenterComputer Motion, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200340
200510
200610
200910
FIG. 1 — Lineage of K030240, 1993–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K973700Hermes Operating Room Control Center
Summary page 1
…n General and Plastic Surgery Regulation Number: 876.1500 Regulation Class: Class 11. 3)This device is substantially equivalent to the H E M E S O.R. Control Center, K973700, and the more recent 5 1O(k) for HERMES control of the Skytron Stellar Series O.R. Lights, K024294. 4) The H E M E S O.R. Co…
Computer Motion, Inc.1998—
*K024294Modification to Hermes Operating Room Control Center
Summary page 1
…is substantially equivalent to the H E M E S O.R. Control Center, K973700, and the more recent 5 1O(k) for HERMES control of the Skytron Stellar Series O.R. Lights, K024294. 4) The H E M E S O.R. Control Center is a computer-driven system whose basic function is to offer the surgeon the additional…
Computer Motion, Inc.2003—

Also cleared against K973700: 8 other devices →

What descends from it? (7)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20052
K031979Conmed Integrated Systems Nurses AssistantConmed Integrated Systems (Cmis)20030
K031956Modification to Hermes O.R. Control CenterComputer Motion, Inc.20030
K031720Modification to Hermes O.R. Control CenterComputer Motion, Inc.20030
K031382Modification to Hermes O.R. Control CenterComputer Motion, Inc.20030

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 1 company; a new generation was cleared every 1.8 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K052740 (Conmed Integrated Systems (Cmis), 2005) has gone furthest, with 2 descendants of its own.
  • 8 other devices also cite its predicate K973700.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

The H E M E S @O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP@HR(HEMES-ReadyTM),Valleylab Force FXTMElectro-surgical Unit, Smith & Nephew Dyonics@Access 15 Arthroscopic Fluid…

Read the full statement (204 words)

The H E M E S @O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP@HR(HEMES-ReadyTM),Valleylab Force FXTMElectro-surgical Unit, Smith & Nephew Dyonics@Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics@Vision 635 Digital Image Management System, Skytron Stellar Series O.R. Lights, and Smith & Nephew Dyonics@Power Shaver. It can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a 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 & thoracoscopic 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 grafting where endoscopic visualization in indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the H E M E S O.R. Control Center are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K030240: Modification to Hermes Operating Room Control Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030240

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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