510(k) Report

510(k) · Cleared

Cleared

Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready).

K991444510(k) TraditionalCleared Jun 25, 199960-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 Jun 25, 1999 as substantially equivalent to K990691 (Computer Motion, Inc., 1999) and 1 other predicate after a 60-day review. Its family tree reaches back 5 generations to 1993. 40 later devices descend from it.

Decided
Jun 25, 1999
Review
60 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K931783 (1993). 8 ancestors in all. 40 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 2 other ancestors1996: 1 other ancestor2003: 1 descendant cleared2004: 2 descendants cleared2005: 1 descendant cleared2012: 2 descendants cleared2016: 5 descendants cleared2010: 2 descendants cleared2007: 1 descendant cleared2006: 3 descendants cleared2009: 2 descendants cleared2018: 3 descendants cleared2019: 2 descendants cleared2015: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant cleared2021: 2 descendants cleared2020: 2 descendants cleared2023: 3 descendants cleared2026: 2 descendants cleared2022: 2 descendants cleared2025: 1 descendant cleared2024: 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. · 1998K980787 · Hermes Operating Room Control Center with the Wom 20L Insufflator · Computer Motion, Inc. · 1998K990691 · Hermes Operating Room Control Center · Computer Motion, Inc. · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 11 descendants4 generations forward: 10 descendants5 generations forward: 6 descendants6 generations forward: 4 descendants7 generations forward: 2 descendants8 generations forward: 2 descendants K990691 · Hermes Operating Room Control Center · Computer Motion, Inc. · 1999K980787 · Hermes Operating Room Control Center with the Wom 20L Insufflator · Computer Motion, Inc. · 1998K973700 · 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+5
  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 backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
  5. 1 generation backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
  6. This deviceK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
  7. Descendant · cites it directly · 39 of its ownK022393 Merdoc SystemStryker Endoscopy · 2003
  8. Descendant · 2 generations on · 14 of its ownK121893 Stryker SDC3 HD Information Management SystemStryker Endoscopy · 2012
  9. Descendant · 2 generations on · 13 of its ownK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
  10. Descendant · 3 generations on · 12 of its ownK160332 Stryker SDC3 HD Information Management System with Wireless Device…Stryker Endoscopy · 2016
  11. Descendant · 3 generations on · 12 of its ownK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22005: 12006: 32007: 12009: 22010: 22012: 22013: 12014: 12015: 12016: 52018: 32019: 22020: 22021: 22022: 22023: 32024: 12025: 12026: 2
2003high 5 (2016) · low 0 (2008)2026

Most influential descendants

Showing 5 of 40 · See all
  • K022393Merdoc SystemStryker Endoscopy · 2003 · cites it directly39descendants
  • K121893Stryker SDC3 HD Information Management SystemStryker Endoscopy · 2012 · 2 generations on14descendants
  • K033135Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004 · 2 generations on13descendants
  • K160332Stryker SDC3 HD Information Management System with Wireless Device Control CapabilityStryker Endoscopy · 2016 · 3 generations on12descendants
  • K053510IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · 3 generations on12descendants
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—
−2K980787Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc.1998—
−1K990691Hermes Operating Room Control CenterComputer Motion, Inc.1999—
0 (this device)K991444Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready).Computer Motion, Inc.1999—
+1K022393Merdoc SystemStryker Endoscopy2003—
+2K121893Stryker SDC3 HD Information Management SystemStryker Endoscopy2012—
+2K033135Stryker Wireless Universal Footswitch SystemStryker Endoscopy2004—
+3K160332Stryker SDC3 HD Information Management System with Wireless Device Control…Stryker Endoscopy2016—
+3K053510IR Wireless Foot SwitchLinemaster Switch Corp.20062

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200510
200630
200710
200920
201020
201220
201310
201410
201510
201650
201830
201920
202020
202120
202220
202330
202410
202510
202620
FIG. 1 — Lineage of K991444, 1993–2026Source: 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
Get a 510(k) Report

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
*K990691Hermes Operating Room Control Center
Summary page 1
…scope for Use in General and Plastic Surgery, Regulation Number 876.1500, Class II. 3) Substantially equivalent to HERMES Operating Room Control Center and Accessories (K990691) and AESOP®3000 (K972699). 4) The HERMES™ Control Center is a computer-driven system whose basic function is to offer the additi…
Computer Motion, Inc.1999—
*K972699Aesop 3000 System and Accessories
Summary page 1
…and Plastic Surgery, Regulation Number 876.1500, Class II. 3) Substantially equivalent to HERMES Operating Room Control Center and Accessories (K990691) and AESOP®3000 (K972699). 4) The HERMES™ Control Center is a computer-driven system whose basic function is to offer the additional option for surgeon s…
Computer Motion, Inc.1997—

Also cleared against K990691: 2 other devices →

What descends from it? (40)

See all 40

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022393Merdoc SystemStryker Endoscopy200339

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 6 years and passes through 1 company; a new generation was cleared every 8 months on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K022393 (Stryker Endoscopy, 2003) has gone furthest, with 39 descendants of its own.
  • 2 other devices also cite its predicate K990691.

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 HERMES™ Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, W.0.M. 20L Insufflator, W.0.M. 2.0L Arthroscopy Pump and AESOP®3000HR (HERMES-Ready). 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…

Read the full statement (142 words)

The HERMES™ Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, W.0.M. 20L Insufflator, W.0.M. 2.0L Arthroscopy Pump and AESOP®3000HR (HERMES-Ready). 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 & thorascopic 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 is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the HERMES ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K991444: Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready)..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991444

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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