510(k) · Cleared
ClearedStraumann Surgical Cassettes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jul 29, 2021 as substantially equivalent to K180791 (Institut Straumann AG, 2018) and 1 other predicate after a 218-day review. Its family tree reaches back 10 generations to 1984. 1 later device descends from it.
- Decided
- Jul 29, 2021
- Review
- 218 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K844002 (1984). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations between
- 3 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 2 generations backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- 1 generation backK191522 Straumann Modular CassetteInstitut Straumann AG · 2019
- This deviceK203753 Straumann Surgical CassettesStraumann USA, LLC · 2021
- Descendant · cites it directly · 0 of its ownK233264 Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr · 2023
Show all 10 generations
- Root · 10 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 9 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 8 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 7 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 6 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 5 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 4 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 3 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 2 generations backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- 1 generation backK191522 Straumann Modular CassetteInstitut Straumann AG · 2019
- This deviceK203753 Straumann Surgical CassettesStraumann USA, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K233264Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −9 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −8 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −7 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −6 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −5 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −4 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −3 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| −2 | K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018 | — |
| −1 | K191522 | Straumann Modular Cassette | Institut Straumann AG | 2019 | — |
| 0 (this device) | K203753 | Straumann Surgical Cassettes | Straumann USA, LLC | 2021 | — |
| +1 | K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | Anthogyr | 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 |
|---|---|---|
| 2023 | 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? (2)
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…§880.6850 Device Classification: II Product Code(s): KCT Classification Panel: General Hospital Predicate Device(s) Primary Predicate: • K180791 – Straumann BLX Surgical Cassette (Institut Straumann AG) Straumann USA, LLC July 29, 2021… | 2018 |
| * | K191522 | Straumann Modular CassetteSummary page 5…3753 – Traditional 510(k) Straumann® Surgical Cassettes 510(k) Summary Reference Devices: • K191522 – Straumann Modular Surgical Cassette (Institut Straumann AG) Device Description Straumann® Surgical Cassettes are designed to h… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | 2023 | 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 37 years and passes through 10 companies; a new generation was cleared every 2.2 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K233264 (Anthogyr, 2023) has gone furthest, with 0 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. 2021, 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 Cassettes are used to organize, store, sterilize and transport surgical instruments and auxiliaries between and during surgical uses. They are indicated to be used in healthcare facilities by healthcare professionals. The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: pre-vacuum steam exposure at 132°C…
Read the full statement (116 words)
The Straumann Cassettes are used to organize, store, sterilize and transport surgical instruments and auxiliaries between and during surgical uses. They are indicated to be used in healthcare facilities by healthcare professionals.
The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: pre-vacuum steam exposure at 132°C (270° F) for 4 minutes, 30 minutes drying time.
The Straumann Cassettes have been validated for a maximum load of 1005 grams for the Surgical Cassettes, 2007 grams for the Osteotome Cassettes, 283 grams for the Bone Block Fixation Cassette and 65 grams for the Screw Container, including cassette and instruments.
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/K203753 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203753: Straumann Surgical Cassettes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203753
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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