510(k) · Cleared
ClearedSurgical Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 4, 2022 as substantially equivalent to K180791 (Institut Straumann AG, 2018) after a 226-day review. Its family tree reaches back 9 generations to 1984. 5 later devices descend from it.
- Decided
- Mar 4, 2022
- Review
- 226 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K844002 (1984). 15 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations between
- 3 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 2 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 1 generation backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- This deviceK212281 Surgical TraysDentsply Sirona, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK220791 Surgical and Prosthetic TraysDentsply Sirona · 2022
- Descendant · cites it directly · 1 of its ownK223672 Instrument Case P1340904Cochlear · 2023
- Descendant · 2 generations on · 0 of its ownK261935 Surgical and Prosthetic TraysDentsply Sirona, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251614 Stainless Steel Surgical KitsDentsply Sirona, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK231604 Instrument CaseCochlear Americas · 2023
Show all 9 generations
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 8 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 7 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 6 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 5 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 4 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 3 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 2 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 1 generation backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- This deviceK212281 Surgical TraysDentsply Sirona, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K220791Surgical and Prosthetic TraysDentsply Sirona · 2022 · cites it directly2descendants
- K223672Instrument Case P1340904Cochlear · 2023 · cites it directly1descendant
- K261935Surgical and Prosthetic TraysDentsply Sirona, Inc. · 2026 · 2 generations on0descendants
- K251614Stainless Steel Surgical KitsDentsply Sirona, Inc. · 2026 · 2 generations on0descendants
- K231604Instrument CaseCochlear Americas · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −8 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −7 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −6 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −5 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −4 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −3 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −2 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| −1 | K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018 | — |
| 0 (this device) | K212281 | Surgical Trays | Dentsply Sirona, Inc. | 2022 | — |
| +1 | K220791 | Surgical and Prosthetic Trays | Dentsply Sirona | 2022 | — |
| +1 | K223672 | Instrument Case P1340904 | Cochlear | 2023 | — |
| +2 | K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | 2026 | — |
| +2 | K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | 2026 | — |
| +2 | K231604 | Instrument Case | Cochlear Americas | 2023 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 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.
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 |
|---|---|---|---|
| * | K180791 | Straumann BLX Surgical CassetteSummary page 4…predicate device identified is the following: Predicate Device Name 510(k) Company Name Straumann BLX Surgical Cassette K180791 Institut Straumann AG 5.4 Device Description: The proposed Surgical Tray is a reusable perforated container that is inte… | 2018 |
What descends from it? (5)
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 10 companies; a new generation was cleared every 3.1 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K220791 (Dentsply Sirona, 2022) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K180791.
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 Trays are intended for organizing, sterilizing and storing of instruments. The Surgical Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch. Sterilization parameters: Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time The tested Surgical Tray represents the worst-case validated load of 513.7g. Do not exceed the following maximum load…
Read the full statement (95 words)
The Surgical Trays are intended for organizing, sterilizing and storing of instruments.
The Surgical Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
Sterilization parameters:
Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time
The tested Surgical Tray represents the worst-case validated load of 513.7g.
Do not exceed the following maximum load:
Product name Article Max Load (g) Vent to Volume
Number Ratio (in-1)
OmniTaper Surgical Tray 68015282 513.7 0.033
PrimeTaper Surgical Tray 68015321 513.7 0.033
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212281: Surgical Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212281
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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