510(k) · Cleared
ClearedWashtrays
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 Jan 16, 2024 as substantially equivalent to K212932 (Nobel Biocare Services AG, 2021) after a 270-day review. Its family tree reaches back 11 generations to 1984.
- Decided
- Jan 16, 2024
- Review
- 270 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 backK181075 PureSet TrayNobel Biocare AB · 2018
- 2 generations backK191475 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate…Nobel Biocare AB · 2019
- 1 generation backK212932 Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite /…Nobel Biocare Services AG · 2021
- This deviceK231144 WashtraysDentsply Sirona · 2024
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 backK181075 PureSet TrayNobel Biocare AB · 2018
- 2 generations backK191475 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate…Nobel Biocare AB · 2019
- 1 generation backK212932 Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite /…Nobel Biocare Services AG · 2021
- This deviceK231144 WashtraysDentsply Sirona · 2024
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 | K181075 | PureSet Tray | Nobel Biocare AB | 2018 | — |
| −2 | K191475 | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic… | Nobel Biocare AB | 2019 | — |
| −1 | K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace… | Nobel Biocare Services AG | 2021 | — |
| 0 (this device) | K231144 | Washtrays | Dentsply Sirona | 2024 | — |
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 |
|---|---|---|---|
| * | K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC…Summary page 4…me NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace SelectTM TC PureSet™ Tray 510(k) K212932 Company Name Nobel Biocare AB Classification Name: Sterilization Wrap Containers, Trays, Casset… | 2021 |
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 40 years and passes through 10 companies; a new generation was cleared every 2.2 years on median.
- None of the 17 ancestors has a recall.
- 1 other device also cites its predicate K212932.
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. 2024, 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?
Washtrays are intended for organizing, cleaning, sterilizing and storing of instruments. The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container. 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: Product name Article Dimensions Maximum…
Read the full statement (132 words)
Washtrays are intended for organizing, cleaning, sterilizing and storing of instruments.
The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container.
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:
Product name Article Dimensions Maximum Load Vent to Volume Ratio
Number Length x (g) (in-1)
Width x
Height (in)
OmniTaper Washtray 68015271 1107.3 2.54
OmniTaper Washtray GS 68015354 1107.3 2.54
10.83
PrimeTaper Washtray 68015323 X 1107.3 2.54
6.93 1107.3
PrimeTaper Washtray GS 68017267 X 2.54
Washtray 2.32 1107.3
31071000 2.54
Astra Tech Implant System EV
Washtray 1107.3
31071020 2.54
GS Astra Tech Implant System EV
Ankylos Washtray 31036600 1107.3 2.54
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231144: Washtrays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231144
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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