510(k) · Cleared
ClearedFiness Endoscope Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entellus Medical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Feb 2, 2011 as substantially equivalent to K013003 (Advanced Sterilization Products, 2002) after a 93-day review. Its family tree reaches back 1 generation to 2002. 22 later devices descend from it.
- Decided
- Feb 2, 2011
- Review
- 93 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013003 (2002). 22 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013003 Aptimax Instrument Tray, Instrument Mat and Instrument HolderAdvanced Sterilization Products · 2002
- This deviceK103213 Finess Endoscope Sterilization TrayEntellus Medical, Inc. · 2011
- Descendant · cites it directly · 19 of its ownK133942 Endoscope Sterilization TrayIntuitive Surgical · 2014
- Descendant · 2 generations on · 16 of its ownK142937 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2015
- Descendant · 3 generations on · 15 of its ownK151450 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2016
- Descendant · 4 generations on · 14 of its ownK170640 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2017
- Descendant · 5 generations on · 13 of its ownK180964 Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2018
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K133942Endoscope Sterilization TrayIntuitive Surgical · 2014 · cites it directly19descendants
- K142937Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2015 · 2 generations on16descendants
- K151450Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2016 · 3 generations on15descendants
- K170640Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2017 · 4 generations on14descendants
- K180964Endoscope Sterilization TrayIntuitive Surgical, Inc. · 2018 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013003 | Aptimax Instrument Tray, Instrument Mat and Instrument Holder | Advanced Sterilization Products | 2002 | — |
| 0 (this device) | K103213 | Finess Endoscope Sterilization Tray | Entellus Medical, Inc. | 2011 | — |
| +1 | K133942 | Endoscope Sterilization Tray | Intuitive Surgical | 2014 | — |
| +2 | K142937 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2015 | — |
| +3 | K151450 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2016 | — |
| +4 | K170640 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2017 | — |
| +5 | K180964 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 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 |
|---|---|---|---|
| * | K013003 | Aptimax Instrument Tray, Instrument Mat and Instrument HolderSummary page 2…l evaluations were conducted. 8. Conclusion: The FinESS Endoscope Sterilization Tray is substantially equivalent to the predicate device, APTIMAX Instrument Tray [K013003]. The device has the same intended use, similar indication for use, and similar technological characteristics as the predicate… | 2002 |
What descends from it? (22)
See all 222 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?
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. 2011, 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 FinESS Endoscope Sterilization Tray is intended for use to encase and protect the FinESS Endoscope for sterilization in STERRAD IOONX using the standard cycle setting and NX Sterilization Systems using the advanced cycle setting.
* The sterilization cycle parameters of the STERRAD sterilizers are preset by the manufacturer and are not adjustable.
* The maximum product load per FinESS Endoscope Sterilization Tray includes 1 FinESS Endoscope and 2 light post adapters.
The FinESS 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/K103213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103213: Finess 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/K103213
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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