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, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Sep 4, 2026 as substantially equivalent to K220791 (Dentsply Sirona, 2022) after an 87-day review. Its family tree reaches back 11 generations to 1984.
- Decided
- Sep 4, 2026
- Review
- 87 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K844002 (1984). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 7 generations between
- 3 generations backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- 2 generations backK212281 Surgical TraysDentsply Sirona, Inc. · 2022
- 1 generation backK220791 Surgical and Prosthetic TraysDentsply Sirona · 2022
- This deviceK261935 Surgical and Prosthetic TraysDentsply Sirona, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 10 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 9 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 8 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 7 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 6 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 5 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 4 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 3 generations backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- 2 generations backK212281 Surgical TraysDentsply Sirona, Inc. · 2022
- 1 generation backK220791 Surgical and Prosthetic TraysDentsply Sirona · 2022
- This deviceK261935 Surgical and Prosthetic TraysDentsply Sirona, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −10 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −9 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −8 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −7 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −6 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −5 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −4 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| −3 | K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018 | — |
| −2 | K212281 | Surgical Trays | Dentsply Sirona, Inc. | 2022 | — |
| −1 | K220791 | Surgical and Prosthetic Trays | Dentsply Sirona | 2022 | — |
| 0 (this device) | K261935 | Surgical and Prosthetic Trays | 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 |
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 |
|---|---|---|---|
| * | K220791 | Surgical and Prosthetic TraysSummary page 6…he following: Primary Predicate Device Name 510(k) Company Name Surgical and Prosthetic Trays K220791 Dentsply Sirona Traditional 510(k)-Surgical and Prosthetic Tray 1 of 8 Den… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 42 years and passes through 11 companies; a new generation was cleared every 3.1 years on median.
- None of the 17 ancestors has a recall.
- 1 other device also cites its predicate K220791.
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. 2026, 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. Sterilization parameters Pre-vacuum steam at 132°C (270°F) for 4 minutes with a 20 minute dry time. Do not exceed the worst-case validated maximum load: Item Number: 68015277 Product Name…
Read the full statement (290 words)
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.
Sterilization parameters
Pre-vacuum steam at 132°C (270°F) for 4 minutes with a 20 minute dry time.
Do not exceed the worst-case validated maximum load:
Item Number: 68015277
Product Name: Astra Tech Implant System EV Surgical Tray
Maximum Load (gram): 719.5
Vent to Volume Ratio (inch-1): 0.031
Item Number: 68017201
Product Name: Astra Tech Implant System EV Surgical Tray GS
Maximum Load (gram): 719.5
Vent to Volume Ratio (inch-1): 0.031
Item Number: 24349
Product Name: Surgical Tray
Maximum Load (gram): 1024.8
Vent to Volume Ratio (inch-1): 0.033
Item Number:31036503
Product Name: Ankylos Surgical Kit Manual ABC
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036513
Product Name: Ankylos Surgical Kit Manual AB
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036523
Product Name: Ankylos Surgical Kit Motor AB Reamer
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036530
Product Name: Ankylos Surgical Kit Guided Surgery
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036531
Product Name: Ankylos Surgical Kit Tray Guided Surgery (empty)
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036540
Product Name: Ankylos Surgical Kit Tray ABC Empty
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036542
Product Name: Ankylos Surgical Kit Tray motor AB Reamer Empty
Maximum Load (gram): 810.6
Vent to Volume Ratio (inch-1): 1.53
Item Number: 31036165
Product Name: Ankylos Prosthetic Tray Mini
Maximum Load (gram): 64
Vent to Volume Ratio (inch-1): 0.24
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261935: 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/K261935
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026