510(k) · Cleared
ClearedPureSet Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Sep 27, 2018 as substantially equivalent to K163600 (Nobel Biocare AB, 2018) after a 156-day review. Its family tree reaches back 8 generations to 1984. 5 later devices descend from it.
- Decided
- Sep 27, 2018
- Review
- 156 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K844002 (1984). 14 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 7 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 6 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 5 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 4 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 3 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 2 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 1 generation backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- This deviceK181075 PureSet TrayNobel Biocare AB · 2018
- Descendant · cites it directly · 4 of its ownK191475 Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate…Nobel Biocare AB · 2019
- Descendant · cites it directly · 2 of its ownK212932 Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite /…Nobel Biocare Services AG · 2021
- Descendant · 2 generations on · 0 of its ownK260726 Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG · 2026
- Descendant · 2 generations on · 0 of its ownK231144 WashtraysDentsply Sirona · 2024
- Descendant · cites it directly · 0 of its ownK231219 NobelZygoma PureSet™ TrayNobel Biocare Services AG · 2023
Most influential descendants
Showing 5 of 5 · See all- K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray…Nobel Biocare AB · 2019 · cites it directly4descendants
- K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC…Nobel Biocare Services AG · 2021 · cites it directly2descendants
- K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG · 2026 · 2 generations on0descendants
- K231144WashtraysDentsply Sirona · 2024 · 2 generations on0descendants
- K231219NobelZygoma PureSet™ TrayNobel Biocare Services AG · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −7 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −6 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −5 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −4 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −3 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −2 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −1 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| 0 (this device) | K181075 | PureSet Tray | Nobel Biocare AB | 2018 | — |
| +1 | 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 | — |
| +2 | K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | 2026 | — |
| +2 | K231144 | Washtrays | Dentsply Sirona | 2024 | — |
| +1 | K231219 | NobelZygoma PureSet™ Tray | Nobel Biocare Services AG | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K163600 | Kit Boxes and Kit PlatesSummary page 4…(21 CFR 880.6850) Regulatory Class: II Primary Product Code: KCT III. PREDICATE DEVICE Primary predicate: Nobel Biocare – Kit Boxes and Kit Plates (K163600) This predicate has not been subject to a design-related recall. Reference predicate: Medtronic Sofamor Danek – Medtronic Transp… | 2018 |
| † | K152241 | Medtronic Transportation/Sterilization Cassettes | 2016 |
What descends from it? (5)
3 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 34 years and passes through 8 companies; a new generation was cleared every 3.1 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K191475 (Nobel Biocare AB, 2019) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K163600.
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. 2018, 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 Nobel Biocare PureSet Tray is used in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The Nobel Biocare PureSet Trays are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization pouch or sterilization wrap. Sterilization validations for the…
Read the full statement (149 words)
The Nobel Biocare PureSet Tray is used in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The Nobel Biocare PureSet Trays are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization pouch or sterilization wrap. Sterilization validations for the worst-case PureSet Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screw driver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1082 grams (NobelActive/NobelParallel CC PureSet Tray) and 945 grams (NobelReplace CC PureSet Tray).
Method Steam Sterilization
(Moist Heat Sterilization)
Cycle Dynamic-Air-Removal
(fractionated vacuum) Gravity-Displacement
Temperature 132°C 132°C
(270°F) (270°F)
Exposure time for a single-use 4 minutes 15 minutes
pouched device (full-cycle) (full-cycle)
Minimum drying times 20 minutes 30 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181075: PureSet Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181075
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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