510(k) · Cleared
ClearedSurgical and Prosthetic Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on May 3, 2022 as substantially equivalent to K212281 (Dentsply Sirona, Inc., 2022) after a 46-day review. Its family tree reaches back 10 generations to 1984. 2 later devices descend from it.
- Decided
- May 3, 2022
- Review
- 46 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K844002 (1984). 16 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations between
- 3 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 2 generations backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- 1 generation backK212281 Surgical TraysDentsply Sirona, Inc. · 2022
- This deviceK220791 Surgical and Prosthetic TraysDentsply Sirona · 2022
- Descendant · cites it directly · 0 of its ownK261935 Surgical and Prosthetic TraysDentsply Sirona, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251614 Stainless Steel Surgical KitsDentsply Sirona, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 9 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 8 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 7 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 6 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 5 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 4 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 3 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 2 generations backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- 1 generation backK212281 Surgical TraysDentsply Sirona, Inc. · 2022
- This deviceK220791 Surgical and Prosthetic TraysDentsply Sirona · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −9 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −8 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −7 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −6 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −5 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −4 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −3 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| −2 | K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018 | — |
| −1 | K212281 | Surgical Trays | Dentsply Sirona, Inc. | 2022 | — |
| 0 (this device) | K220791 | Surgical and Prosthetic Trays | Dentsply Sirona | 2022 | — |
| +1 | K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | 2026 | — |
| +1 | K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K212281 | Surgical TraysSummary page 4…predicate device identified is the following: Predicate Device Name 510(k) Company Name Surgical Trays K212281 Dentsply Sirona Device Description: The proposed Surgical and Prosthetic Trays are reusable perforated containers that ar… | 2022 |
What descends from it? (2)
2 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 38 years and passes through 11 companies; a new generation was cleared every 3.1 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K261935 (Dentsply Sirona, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K212281.
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. 2022, 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 Surgical and Prosthetic Trays are intended for organizing, sterilizing and storing of instruments.
The Surgical and Prosthetic Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220791: Surgical and Prosthetic Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220791
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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