510(k) · Cleared
Recalled · Class II · 2019Endoscope Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Feb 1, 2019 as substantially equivalent to K180964 (Intuitive Surgical, Inc., 2018) after an 80-day review. Its family tree reaches back 7 generations to 2002. 12 later devices descend from it. It has been recalled once.
- Decided
- Feb 1, 2019
- Review
- 80 days
- Class
- Class II
- Product code
- KCT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K013003 (2002). 12 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK013003 Aptimax Instrument Tray, Instrument Mat and Instrument HolderAdvanced Sterilization Products · 2002
- 6 generations backK103213 Finess Endoscope Sterilization TrayEntellus Medical, Inc. · 2011
- 5 generations backK133942 Endoscope Sterilization TrayIntuitive Surgical · 2014
- 4 generations backK142937 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2015
- 3 generations backK151450 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2016
- 2 generations backK170640 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2017
- 1 generation backK180964 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2018
- This deviceK183139 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2019
- Descendant · cites it directly · 11 of its ownK232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube…Intuitive Surgical, Inc. · 2024 · Recalled
- Descendant · 2 generations on · 2 of its ownK251739 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2026
- Descendant · 2 generations on · 2 of its ownK241284 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK251202 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK243641 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc. · 2024 · cites it directly11descendants
- K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2026 · 2 generations on2descendants
- K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024 · 2 generations on2descendants
- K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2025 · 2 generations on1descendant
- K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K013003 | Aptimax Instrument Tray, Instrument Mat and Instrument Holder | Advanced Sterilization Products | 2002 | — |
| −6 | K103213 | Finess Endoscope Sterilization Tray | Entellus Medical, Inc. | 2011 | — |
| −5 | K133942 | Endoscope Sterilization Tray | Intuitive Surgical | 2014 | — |
| −4 | K142937 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2015 | — |
| −3 | K151450 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2016 | — |
| −2 | K170640 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2017 | — |
| −1 | K180964 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2018 | — |
| 0 (this device) | K183139 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2019 | — |
| +1 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with… | Intuitive Surgical, Inc. | 2024 | 6 |
| +2 | K251739 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2026 | — |
| +2 | K241284 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2024 | — |
| +2 | K251202 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025 | — |
| +2 | K243641 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 KCT? 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 KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 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 |
|---|---|---|---|
| * | K180964 | Endoscope Sterilization TraySummary page 4…ory Committee: General Hospital Predicate Device: Intuitive Surgical, Inc. Endoscope Sterilization Tray (K180964) P a g e 1 of 6 Endoscope S… | 2018 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke… | 2024 | 11 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2019 | Class II | Z-2328-2020 | Device Design | Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K232610 (Intuitive Surgical, Inc., 2024) has gone furthest, with 11 descendants of its own.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, 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 | 3 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes for sterilization in any of the following sterilization machines/cycles: • STERRAD 100NX sterilization system using the Express and DUO cycles • STERRAD 100S sterilization system using the Standard cycle • Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles • Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles •…
Read the full statement (180 words)
The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and
protect compatible da Vinci Xi endoscopes for sterilization in any of the following
sterilization machines/cycles:
• STERRAD 100NX sterilization system using the Express and DUO cycles
• STERRAD 100S sterilization system using the Standard cycle
• 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 Xi Endoscope.
The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of
the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 12.2 lbs. The
Endoscope Sterilization 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
compatible sterilization wrap in order to maintain sterility of the enclosed medical
instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183139: Endoscope Sterilization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183139
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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