510(k) · Cleared
Recalled · Class II · 2024da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument
Cleared on Aug 15, 2022 as substantially equivalent to K203632 (Intuitive Surgical, Inc., 2021) after a 230-day review. Its family tree reaches back 2 generations to 2017. It has been recalled 12 times.
- Decided
- Aug 15, 2022
- Review
- 230 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 12
- Predicates
- 1
Its longest line of descent runs back 2 generations to K170644 (2017). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK170644 da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE…Intuitive Surgical, Inc. · 2017
- 1 generation backK203632 da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da…Intuitive Surgical, Inc. · 2021
- This deviceK214095 da Vinci X/Xi (IS4200/IS4000) 8mm Reusable InstrumentsIntuitive Surgical, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K170644 | da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved… | Intuitive Surgical, Inc. | 2017 | — |
| −1 | K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X… | Intuitive Surgical, Inc. | 2021 | — |
| 0 (this device) | K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments | Intuitive Surgical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 NAY? 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 NAY device
- #1 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X…Summary page 4…ation Class II, 21 CFR 876.1500 Product Codes NAY, GCJ Review Panel General and Plastic Surgery Predicate Devices K203632 (da Vinci X/Xi 8mm Reusable Instruments)… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2024 | Class II | Z-0874-2025 | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Dec 19, 2024 | Class II | Z-0883-2025 | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Dec 19, 2024 | Class II | Z-0872-2025 | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Dec 19, 2024 | Class II | Z-0873-2025 | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Dec 19, 2024 | Class II | Z-0875-2025 | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Dec 19, 2024 | Class II | Z-0877-2025 | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Dec 19, 2024 | Class II | Z-0880-2025 | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Dec 19, 2024 | Class II | Z-0881-2025 | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Dec 19, 2024 | Class II | Z-0879-2025 | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Dec 19, 2024 | Class II | Z-0882-2025 | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Dec 19, 2024 | Class II | Z-0876-2025 | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Dec 19, 2024 | Class II | Z-0878-2025 | Process change control | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K203632.
How does its category compare?
All NAY devicesNAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NAY
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NAY
117in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NAY
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NAY
48,456in 2025
MAUDE reports naming product code NAY, 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 | 0 | — | 11 | 133 |
| 2008 | 4 | 189 | 3 | 224 |
| 2009 | 3 | 253 | 1 | 380 |
| 2010 | 1 | — | 0 | 623 |
| 2011 | 7 | 191 | 2 | 501 |
| 2012 | 4 | 106 | 1 | 1,552 |
| 2013 | 4 | 144 | 6 | 6,217 |
| 2014 | 9 | 143 | 25 | 6,135 |
| 2015 | 3 | 99 | 3 | 1,722 |
| 2016 | 8 | 197 | 1 | 1,077 |
| 2017 | 16 | 107 | 1 | 1,049 |
| 2018 | 15 | 152 | 2 | 1,074 |
| 2019 | 8 | 73 | 5 | 1,154 |
| 2020 | 9 | 212 | 0 | 1,558 |
| 2021 | 11 | 61 | 3 | 1,997 |
| 2022 | 6 | 57 | 3 | 5,727 |
| 2023 | 5 | 141 | 2 (1) | 10,898 |
| 2024 | 10 | 126 | 40 | 12,872 |
| 2025 | 16 | 117 | 1 | 48,456 |
| 2026 | 7 | 89 | 4 (1) | — |
What is it indicated for?
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) and the Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) is intended to 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…
Read the full statement (161 words)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) and the Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) is intended to 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, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214095: da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214095
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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