510(k) · Cleared
ClearedKlockner Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soadco, S.L. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Dec 18, 2024 as substantially equivalent to K173642 (Soadco, S.L., 2018) after a 79-day review. Its family tree reaches back 8 generations to 1984.
- Decided
- Dec 18, 2024
- Review
- 79 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K844002 (1984). 11 ancestors in all. No later device cites it as a predicate yet.
- 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 backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 3 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 2 generations backK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- 1 generation backK173642 Klockner Surgical BoxSoadco, S.L. · 2018
- This deviceK243128 Klockner KitsSoadco, S.L. · 2024
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 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −3 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −2 | K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| −1 | K173642 | Klockner Surgical Box | Soadco, S.L. | 2018 | — |
| 0 (this device) | K243128 | Klockner Kits | Soadco, S.L. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K173642 | Klockner Surgical BoxSummary page 7…ontrol Devices) Reviewing Division Division of Health Technology 4C (Infection Control Devices) PREDICATE DEVICE INFORMATION K173642, KLOCKNER Surgical Box, SOADCO, S.L. K212068, Biotech Dental Kits, Biotech Dental SAS The primary predicate device is K173642. T… | 2018 |
| † | K212068 | Biotech Dental Kits | 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 8 companies; a new generation was cleared every 3.6 years on median.
- None of the 11 ancestors has a recall.
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?
Indications for Use for the KIT WT SNIPER KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles…
Read the full statement (1,108 words)
Indications for Use for the KIT WT SNIPER
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization – Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT SNIPER and the associated instruments is 820 grams.
The weight of the empty KIT WT SNIPER is 620 grams.
The KIT WT SNIPER is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT SNIPER JSI
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization – Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT SNIPER JSI and the associated instruments is 920 grams.
The weight of the empty KIT WT SNIPER JSI is 620 grams.
The KIT WT SNIPER JSI is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT INTERNA
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization – Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT INTERNA and the associated instruments is 840 grams.
The weight of the empty KIT WT INTERNA is 620 grams.
The KIT WT INTERNA is exclusively indicated to assist in the installation of implants of both the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT VEGA
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization – Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT VEGA and the associated instruments is 820 grams.
The weight of the empty KIT WT VEGA is 620 grams.
The KIT WT VEGA is exclusively indicated to assist in the installation of implants of the VEGA® family and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT WT ESSENTIAL
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization – Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT WT ESSENTIAL and the associated instruments is 800 grams.
The weight of the empty KIT WT ESSENTIAL is 620 grams.
The KIT WT ESSENTIAL is exclusively indicated to assist in the installation of implants of the ESSENTIAL® CONE family and is not compatible with other lines and systems of other manufacturers.
Indications for Use for the KIT MEDGUIDE®
KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices.
KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization – Exposure at 134 °C for 4 minutes and 16 minutes dry time.
KLOCKNER KITS are intended for sterilization of non-porous loads.
KLOCKNER KITS are recommended not to be stacked during sterilization.
The combined weight of the KIT MEDGUIDE® and the associated instruments is 240 grams.
The weight of the empty KIT MEDGUIDE® is 160 grams.
The KIT MEDGUIDE® is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243128: Klockner Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243128
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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