510(k) · Cleared
ClearedEndoscope Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Aug 1, 2014 as substantially equivalent to K103213 (Entellus Medical, Inc., 2011) after a 221-day review. Its family tree reaches back 2 generations to 2002. 19 later devices descend from it.
- Decided
- Aug 1, 2014
- Review
- 221 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013003 (2002). 19 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK013003 Aptimax Instrument Tray, Instrument Mat and Instrument HolderAdvanced Sterilization Products · 2002
- 1 generation backK103213 Finess Endoscope Sterilization TrayEntellus Medical, Inc. · 2011
- This deviceK133942 Endoscope Sterilization TrayIntuitive Surgical · 2014
- Descendant · cites it directly · 16 of its ownK142937 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2015
- Descendant · 2 generations on · 15 of its ownK151450 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2016
- Descendant · 3 generations on · 14 of its ownK170640 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2017
- Descendant · 4 generations on · 13 of its ownK180964 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2018
- Descendant · 5 generations on · 12 of its ownK183139 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2019 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K142937Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2015 · cites it directly16descendants
- K151450Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2016 · 2 generations on15descendants
- K170640Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2017 · 3 generations on14descendants
- K180964Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2018 · 4 generations on13descendants
- K183139Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2019 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013003 | Aptimax Instrument Tray, Instrument Mat and Instrument Holder | Advanced Sterilization Products | 2002 | — |
| −1 | K103213 | Finess Endoscope Sterilization Tray | Entellus Medical, Inc. | 2011 | — |
| 0 (this device) | K133942 | Endoscope Sterilization Tray | Intuitive Surgical | 2014 | — |
| +1 | K142937 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2015 | — |
| +2 | K151450 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2016 | — |
| +3 | K170640 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2017 | — |
| +4 | K180964 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2018 | — |
| +5 | K183139 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 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 |
|---|---|---|---|
| * | K103213 | Finess Endoscope Sterilization TraySummary page 4…sification Advisory Committee: General Hospital Predicate Device: Entellus Medical FinESS Endoscope Sterilization Tray (K103213) Page 1 K133942… | 2011 |
What descends from it? (19)
See all 192 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142937 (Intuitive Surgical, Inc., 2015) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K103213.
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. 2014, 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 da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in the STERRAD 100NX sterilization system using the Express cycle and in the STERRAD 100S sterilization system using the standard cycle. The sterilization cycle parameters of the sterilizers are preset by the manufacturer and are not adjustable. The maximum product load per tray is 1 da Vinci…
Read the full statement (112 words)
The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in the STERRAD 100NX sterilization system using the Express cycle and in the STERRAD 100S sterilization system using the standard cycle. The sterilization cycle parameters of the sterilizers are preset by the manufacturer and are not adjustable. The maximum product load per tray is 1 da Vinci Xi Endoscope. The max weight of tray and endoscope is 7.7 lbs.
The Intuitive Surgical Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133942: 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/K133942
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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