510(k) · Cleared
Recalled · Class II · 2016IS4000 Stapler 30 Instrument and Stapler 30 Reloads
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 Mar 4, 2016 as substantially equivalent to K140553 (Intuitive Surgical, Inc., 2014) and 1 other predicate after a 191-day review. Its family tree reaches back 1 generation to 2003. 3 of the 17 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 4, 2016
- Review
- 191 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K033269 (2003). 2 ancestors in all. 14 later devices descend from it, 2 citing it directly. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK033269 Endopath Endocutter Gray Cartridge, Model 6R45M/Gray Cartridge ReloadEthicon Endo-Surgery, Inc. · 2003
- This deviceK152421 IS4000 Stapler 30 Instrument and Stapler 30 ReloadsIntuitive Surgical, Inc. · 2016
- Descendant · cites it directly · 12 of its ownK170508 EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads…Intuitive Surgical, Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK173721 SureForm 60 and SureForm 60 ReloadsIntuitive Surgical · 2018 · Recalled
- Descendant · 3 generations on · 5 of its ownK183224 SureForm 45, SureForm 45 ReloadsIntuitive Surgical · 2019 · Recalled
- Descendant · 2 generations on · 4 of its ownK190999 SureForm 45 Curved Tip, SureForm 45 Gray ReloadIntuitive Surgical, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 4 of its ownK181395 Universal Cannula Seal (5-12 mm)Intuitive Surgical, Inc. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 14 · See all- K170508EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30…Intuitive Surgical, Inc. · 2017 · cites it directly12descendants
- K173721SureForm 60 and SureForm 60 ReloadsIntuitive Surgical · 2018 · 2 generations on6descendants
- K183224SureForm 45, SureForm 45 ReloadsIntuitive Surgical · 2019 · 3 generations on5descendants
- K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadIntuitive Surgical, Inc. · 2019 · 2 generations on4descendants
- K181395Universal Cannula Seal (5-12 mm)Intuitive Surgical, Inc. · 2018 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033269 | Endopath Endocutter Gray Cartridge, Model 6R45M/Gray Cartridge Reload | Ethicon Endo-Surgery, Inc. | 2003 | — |
| 0 (this device) | K152421 | IS4000 Stapler 30 Instrument and Stapler 30 Reloads | Intuitive Surgical, Inc. | 2016 | — |
| +1 | K170508 | EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist… | Intuitive Surgical, Inc. | 2017 | — |
| +2 | K173721 | SureForm 60 and SureForm 60 Reloads | Intuitive Surgical | 2018 | 3 |
| +3 | K183224 | SureForm 45, SureForm 45 Reloads | Intuitive Surgical | 2019 | 1 |
| +2 | K190999 | SureForm 45 Curved Tip, SureForm 45 Gray Reload | Intuitive Surgical, Inc. | 2019 | 1 |
| +2 | K181395 | Universal Cannula Seal (5-12 mm) | Intuitive Surgical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 1 |
| 2023 | 2 | 1 |
| 2024 | 2 | 1 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
3 devices in this family have a Class I recall. 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140553 | Endowrist Stapler 45 and Stapler 45 ReloadsSummary page 4…tee: General and Plastic Surgery Predicate Device: 1. IS4000 EndoWrist® Stapler 45 and Stapler 45 Reloads – K140553 (primary) 2. ENDOPATH Endocutter with Gray Cartridge – K033269 (seco… | 2014 |
| * | K033269 | Endopath Endocutter Gray Cartridge, Model 6R45M/Gray Cartridge ReloadSummary page 4…er 45 Reloads – K140553 (primary) 2. ENDOPATH Endocutter with Gray Cartridge – K033269 (secondary) Device Description: The Intuitive Surgical IS4000 EndoWrist® Stapler 30 and Stapler 30 Reloads is a reusable surgica… | 2003 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2016 | Class II | Z-2349-2016 | Software design | An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend |
| Jul 14, 2016 | Class II | Z-2350-2016 | Software design | An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend |
| Jul 14, 2016 | Class II | Z-2677-2016 | Nonconforming Material/Component | Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K222839EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm…Intuitive Surgical, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K2119978 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsIntuitive Surgical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K2416388mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsIntuitive Surgical, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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. 2016, 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 EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152421: IS4000 Stapler 30 Instrument and Stapler 30 Reloads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152421
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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