510(k) · Cleared
Recalled · Class II · 20135MM Flared Cannula Model 420262, 8MM Flared Cannula Model 420319
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 Feb 4, 2011 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) after a 227-day review. Its family tree reaches back 3 generations to 1994. 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 4, 2011
- Review
- 227 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930667 (1994). 5 ancestors in all, the oldest K931340 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 2 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 1 generation backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- This deviceK101743 5MM Flared Cannula Model 420262, 8MM Flared Cannula Model 420319Intuitive Surgical, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK123329 DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK210478 8mm Monopolar Curved ScissorsIconocare Health · 2022
- Descendant · 2 generations on · 0 of its ownK173415 EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK170641 da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014 · cites it directly3descendants
- K2104788mm Monopolar Curved ScissorsIconocare Health · 2022 · 2 generations on0descendants
- K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc. · 2018 · 2 generations on0descendants
- K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −2 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −1 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| 0 (this device) | K101743 | 5MM Flared Cannula Model 420262, 8MM Flared Cannula Model 420319 | Intuitive Surgical, Inc. | 2011 | — |
| +1 | K123329 | DA Vinvi Surgical System | Intuitive Surgical, Inc. | 2014 | — |
| +2 | K210478 | 8mm Monopolar Curved Scissors | Iconocare Health | 2022 | — |
| +2 | K173415 | EndoWrist 5mm Thoracic Grasper | Intuitive Surgical, Inc. | 2018 | — |
| +2 | K170641 | da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes | Intuitive Surgical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Summary page 1…Accessories, 21 CER 876,1500, NAY(LFL) Predicate Device: Intuitive Surgical, Inc. K990144, da Vinci Endoscoplc Instrument Control System (Model IS1000) and Endloscopic… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123329 | DA Vinvi Surgical System | 2014 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 6, 2013 | Class II | Z-1463-2013 | Use error | Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K123329 (Intuitive Surgical, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 20 other devices also cite its predicate K990144.
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. 2011, 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 Flared Cannulae are intended to be used with the da Vinci Surgical System (da Vinci S (Model IS2000) or da Vinci Si (Model IS3000)) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101743: 5MM Flared Cannula Model 420262, 8MM Flared Cannula Model 420319.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101743
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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