# K232610: da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Mar 14, 2024 after 199 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K930667 (1994). 143 ancestors in all.
11 later devices descend from it; 7 cite it directly.
3 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131861: DA Vinci Surgical System, Endowrist Instruments and Accessories, Intuitive Surgical, Inc. (2014) Summary page 6.
- K141077: DA Vinci Firefly Imaging System, Intuitive Surgical, Inc. (2014) Summary page 6.
- K151794: da Vinci Xi Surgical System, Intuitive Surgical, Inc. (2016) Summary page 6.
- K152892: da Vinci Xi Surgical System, Intuitive Surgical (2016) Summary page 6.
- K161271: da Vinci Xi Surgical System, Intuitive Surgical, Inc. (2016) Summary page 6.
- K191529: da Vinci Xi Surgical System, da Vinci X Surgical System, Intuitive Surgical (2020) Summary page 6.
- K152578: da Vinci Surgical System, Model IS4000, Intuitive Surgical, Inc. (2016) Summary page 6.
- K153276: da Vinci Xi Surgical System, Intuitive Surgical, Inc. (2016) Summary page 6.
- K161178: da Vinci Xi Surgical System, Intuitive Surgical, Inc. (2017) Summary page 6.
- K170713: da Vinci Xi Surgical System, Intuitive Surgical, Inc. (2017) Summary page 6.
- K171632: da Vinci Xi Surgical System, Intuitive Surgical, Inc. (2017) Summary page 6.
- K171699: da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System, Intuitive Surgical, Inc. (2017) Summary page 6.
- K172643: da Vinci Xi Surgical System; da Vinci X Surgical System, Intuitive Surgical, Inc. (2018) Summary page 6.
- K173585: da Vinci Xi Surgical System, da Vinci X Surgical System, Intuitive Surgical, Inc. (2018) Summary page 6.
- K173842: da Vinci Xi Surgical System, da Vinci X Surgical System, Intuitive Surgical, Inc. (2018) Summary page 6.
- K182140: da Vinci Xi Surgical System, da Vinci X Surgical System, Intuitive Surgical, Inc. (2018) Summary page 6.
- K183086: da Vinci X and Xi Surgical System, Intuitive Surgical, Inc. (2020) Summary page 6.
- K202834: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200), Intuitive Surgical, Inc. (2020) Summary page 6.
- K211784: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200), Intuitive Surgical, Inc. (2021) Summary page 6.
- K223080: da Vinci X Surgical System  (IS4200), da Vinci Xi Surgical System (IS4000), Intuitive Surgical, Inc. (2022) Summary page 6.
- K231224: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200), Intuitive Surgical, Inc. (2023) Summary page 6.
- K201361: Pneumoclear, W.O.M. World of Medicine GmbH (2020) Summary page 6.
- K183139: Endoscope Sterilization Tray, Intuitive Surgical, Inc. (2019) Summary page 6.

## Cited in the summary but kept off the family tree
- K172086: Matira™ Anterior Cervical System, Kalitec Direct, LLC (2017). Our reading of the summary gave K172086, FDA’s number for Matira™ Anterior Cervical System (Kalitec Direct, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intuitive Surgical da Vinci Surgical System, Model IS4000”. Kept off the family tree. Summary page 6.

## Most influential descendants
- K251739: da Vinci Surgical System (IS5000) (2026), 2 descendants of its own
- K241284: da Vinci Surgical System (IS5000) (2024), 2 descendants of its own
- K251202: da Vinci Surgical System (IS5000) (2025), 1 descendant of its own
- K243641: da Vinci Surgical System (IS5000) (2024), 1 descendant of its own
- K261823: da Vinci Surgical System, Model IS5000 (2026), 0 descendants of its own

## Recalls of this device
- Apr 24, 2026 · Class II · Z-2310-2026: Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camer
- Dec 30, 2025 · Class II · Z-1355-2026: Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of bo
- Nov 17, 2025 · Class II · Z-1428-2026: An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
- Nov 7, 2025 · Class II · Z-1232-2026: Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Mani
- Feb 26, 2025 · Class II · Z-1325-2025: Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
- Aug 21, 2024 · Class II · Z-0964-2026: Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray posit

## Indications for use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. Contraindication: Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures. The da Vinci Insufflator with compatible tube sets is intended for use in diagnostic and/or therapeutic endoscopic and thoracoscopic procedures to distend a cavity by filling it with gas. Intended cavities for this device include abdominal and thoracic cavities in adult and bariatric patients. The Intuitive da Vinci 5 endoscope tray is intended for use to encase and protect compatible da Vinci endoscopes for sterilization in any of the following sterilization machines and cycles: • STERRAD 100NX sterilization system using the Flex, Express, and DUO cycles • STERIS V-PRO maX 2 using the Non Lumen, Flexible, or Lumen cycles • STERIS V-PRO maX using the Non Lumen, Flexible, or Lumen cycles • STERIS V-PRO 1 Plus using the Non Lumen or Lumen cycles • STERIS V-PRO 1 using the V-PRO/Lumen cycle The sterilization-cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci 5 endoscope. The length of the da Vinci 5 endoscopes is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 13 lbs. The endoscope tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally-marketed, validated, FDA-cleared STERRAD and STERIS V-PRO compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

Source page: https://510kreport.com/device/K232610
Methodology: https://510kreport.com/methodology