510(k) · Cleared
Recalled · Class II · 2025Mini Sterilizable Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Direct Sybron Manufacturing, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Aug 6, 2020 as substantially equivalent to K142519 (Implant Direct Sybron Manufacturing, LLC, 2015) after a 127-day review. Its family tree reaches back 7 generations to 1984. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 6, 2020
- Review
- 127 days
- Class
- Class II
- Product code
- KCT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K844002 (1984). 10 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 5 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 4 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 3 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 2 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 1 generation backK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- This deviceK200858 Mini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 2020
- Descendant · cites it directly · 2 of its ownK202524 Standard Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK253988 LiteSet TraysNobel Biocare AB · 2026
- Descendant · 2 generations on · 0 of its ownK251756 Sterilization TraysParagon Implant Mfg., LLC · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −6 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −5 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −4 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −3 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −2 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −1 | K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| 0 (this device) | K200858 | Mini Sterilizable Tray | Implant Direct Sybron Manufacturing, LLC | 2020 | — |
| +1 | K202524 | Standard Sterilizable Tray | Implant Direct Sybron Manufacturing, LLC | 2021 | — |
| +2 | K253988 | LiteSet Trays | Nobel Biocare AB | 2026 | — |
| +2 | K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K142519 | InterActive Complete Surgical TraySummary page 4…fication Name: Sterilization Wrap (21 CFR 880.6850) Regulatory Class: II Product Code: KCT III.PREDICATE DEVICE Predicate (primary) InterActive Complete Surgical Tray (K142519) IV. DEVICE DESCRIPTION The Mini Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instrumen… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202524 | Standard Sterilizable Tray | 2021 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2025 | Class II | Z-2172-2025 | Under Investigation by firm | The Drill stop kit contains incorrect components. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 7 companies; a new generation was cleared every 3.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K202524 (Implant Direct Sybron Manufacturing, LLC, 2021) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K142519.
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. 2020, 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 Mini Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles: Pre-vacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time. Gravity Steam – At 132°C for 15 minutes with a 30 minutes dry…
Read the full statement (123 words)
The Mini Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles:
Pre-vacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time.
Gravity Steam – At 132°C for 15 minutes with a 30 minutes dry time.
-The tray is intended for sterilization of non-porous loads.
-Do not stack trays during sterilization.
-The tested Tray represents the worst case validated load of 354.10 grams.
-Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Mini Sterilizable Tray.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200858: Mini Sterilizable Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200858
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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