510(k) · Cleared
ClearedTHS Instrument Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Oct 17, 2012 as substantially equivalent to K012105 (Symmetry Medical, Inc., 2002) and 1 other predicate after a 202-day review. Its family tree reaches back 5 generations to 1984. 30 later devices descend from it.
- Decided
- Oct 17, 2012
- Review
- 202 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K844002 (1984). 9 ancestors in all. 30 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 4 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 3 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 2 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 1 generation backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- This deviceK120947 THS Instrument TrayHologic, Inc. · 2012
- Descendant · cites it directly · 29 of its ownK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- Descendant · 2 generations on · 18 of its ownK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- Descendant · 3 generations on · 11 of its ownK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- Descendant · 4 generations on · 5 of its ownK212281 Surgical TraysDentsply Sirona, Inc. · 2022
- Descendant · 3 generations on · 5 of its ownK181075 PureSet TrayNobel Biocare AB · 2018
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K152241Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016 · cites it directly29descendants
- K163600Kit Boxes and Kit PlatesNobel Biocare AB · 2018 · 2 generations on18descendants
- K180791Straumann BLX Surgical CassetteInstitut Straumann AG · 2018 · 3 generations on11descendants
- K212281Surgical TraysDentsply Sirona, Inc. · 2022 · 4 generations on5descendants
- K181075PureSet TrayNobel Biocare AB · 2018 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −4 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −3 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −2 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −1 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| 0 (this device) | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| +1 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| +2 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| +3 | K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018 | — |
| +4 | K212281 | Surgical Trays | Dentsply Sirona, Inc. | 2022 | — |
| +3 | K181075 | PureSet Tray | Nobel Biocare AB | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K012105 | Polyvac Surgical Instrument Delivery SystemSummary page 1…redicate Device: Tradenamne: PolyVac Surgical Instrument Delivery System Submitter / 510(k) Holder: Symmetry Medical, Inc. 510(k) if's: K012105 and K040223 4. Device Description: The THS Sterilization Tray will secure the reusable TUS components during… | 2002 |
| * | K040223 | Polyvac Instrument Delivery SystemSummary page 1…ice: Tradenamne: PolyVac Surgical Instrument Delivery System Submitter / 510(k) Holder: Symmetry Medical, Inc. 510(k) if's: K012105 and K040223 4. Device Description: The THS Sterilization Tray will secure the reusable TUS components during autoclave… | 2004 |
What descends from it? (30)
See all 301 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152241 | Medtronic Transportation/Sterilization Cassettes | 2016 | 29 |
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 28 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K152241 (Medtronic Sofamor Danek USA, Inc., 2016) has gone furthest, with 29 descendants of its own.
- 20 other devices also cite its predicate K012105.
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. 2012, 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 THS Sterilization Tray is used to enclose, protect, and organize the THS scopes, diagnostic sheath, and associated accessory components, and to facilitate the sterilization process by allowing sterilant penetration and air removal when used in conjunction with an approved sterilization wrap. The THS Instrument tray is not designed to maintain sterility by itself, but when used in conjunction with an approved sterilization wrap sterility of the…
Read the full statement (130 words)
The THS Sterilization Tray is used to enclose, protect, and organize the THS scopes, diagnostic sheath, and associated accessory components, and to facilitate the sterilization process by allowing sterilant penetration and air removal when used in conjunction with an approved sterilization wrap.
The THS Instrument tray is not designed to maintain sterility by itself, but when used in conjunction with an approved sterilization wrap sterility of the enclosed medical device is maintained based on the specific time that the maintenance of sterility for that specific wrap as cleared by the FDA.
The THS Sterilization Tray is to be sterilized using one of the following cycles:
Steam Autoclave Wrapped
Pre-Vacuum Parameters: 270'F for 4 minutes
Pre-Vacuum Dry Time: 30 minutes
Gravity Parameters: 250'F for 30 minutes
Gravity Dry Time: 30 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120947: THS Instrument Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120947
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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