510(k) · Cleared
ClearedStraumann BLX Surgical Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jun 21, 2018 as substantially equivalent to K163600 (Nobel Biocare AB, 2018) after an 86-day review. Its family tree reaches back 8 generations to 1984. 11 later devices descend from it.
- Decided
- Jun 21, 2018
- Review
- 86 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. 11 later devices descend from it, 5 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 deviceK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- Descendant · cites it directly · 5 of its ownK212281 Surgical TraysDentsply Sirona, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK220791 Surgical and Prosthetic TraysDentsply Sirona · 2022
- Descendant · cites it directly · 2 of its ownK191522 Straumann Modular CassetteInstitut Straumann AG · 2019
- Descendant · 2 generations on · 1 of its ownK223672 Instrument Case P1340904Cochlear · 2023
- Descendant · cites it directly · 1 of its ownK203753 Straumann Surgical CassettesStraumann USA, LLC · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K212281Surgical TraysDentsply Sirona, Inc. · 2022 · cites it directly5descendants
- K220791Surgical and Prosthetic TraysDentsply Sirona · 2022 · 2 generations on2descendants
- K191522Straumann Modular CassetteInstitut Straumann AG · 2019 · cites it directly2descendants
- K223672Instrument Case P1340904Cochlear · 2023 · 2 generations on1descendant
- K203753Straumann Surgical CassettesStraumann USA, LLC · 2021 · cites it directly1descendant
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) | K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018 | — |
| +1 | K212281 | Surgical Trays | Dentsply Sirona, Inc. | 2022 | — |
| +2 | K220791 | Surgical and Prosthetic Trays | Dentsply Sirona | 2022 | — |
| +1 | K191522 | Straumann Modular Cassette | Institut Straumann AG | 2019 | — |
| +2 | K223672 | Instrument Case P1340904 | Cochlear | 2023 | — |
| +1 | K203753 | Straumann Surgical Cassettes | Straumann USA, LLC | 2021 | — |
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 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K163600 | Kit Boxes and Kit PlatesSummary page 4…21 CFR 880.6850 Classification: Class II Product Codes: KCT 1.3 Predicate Device(s) Primary Predicate: • K163600 – Kit Boxes and Kit Plates, Nobel Biocare AB Reference Devices: • K160730 – Instrument kits, Anthogyr Straumann USA… | 2018 |
| † | K160730 | Instrument kits | 2017 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212281 | Surgical Trays | 2022 | 5 |
| K191522 | Straumann Modular Cassette | 2019 | 2 |
| K203753 | Straumann Surgical Cassettes | 2021 | 1 |
| K242564 | Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant… | 2025 | 0 |
| K201412 | BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO… | 2021 | 0 |
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 9 companies; a new generation was cleared every 3.1 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K212281 (Dentsply Sirona, Inc., 2022) has gone furthest, with 5 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 Straumann BLX Cassette is used in healthcare facilities to organize, enclose, cleaning, sterilize, transport, and store medical devices between surgical uses. The BLX Cassette is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated sterilization wrap.
The BLX Cassette has been validated for a maximum load of 300 grams, including cassette and instruments.
Sterilization parameters: Pre-vacuum steam: 132°C (270° F) for 4 minutes with 20 minutes drying time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180791: Straumann BLX Surgical Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180791
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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