510(k) · Cleared
ClearedSterilization Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon Implant Mfg., LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Nov 14, 2025 as substantially equivalent to K202524 (Implant Direct Sybron Manufacturing, LLC, 2021) after a 158-day review. Its family tree reaches back 9 generations to 1984.
- Decided
- Nov 14, 2025
- Review
- 158 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K844002 (1984). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations between
- 3 generations backK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- 2 generations backK200858 Mini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 2020 · Recalled
- 1 generation backK202524 Standard Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 2021
- This deviceK251756 Sterilization TraysParagon Implant Mfg., LLC · 2025
Show all 9 generations
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 8 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 7 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 6 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 5 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 4 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 3 generations backK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- 2 generations backK200858 Mini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 2020 · Recalled
- 1 generation backK202524 Standard Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 2021
- This deviceK251756 Sterilization TraysParagon Implant Mfg., LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −8 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −7 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −6 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −5 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −4 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −3 | K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| −2 | K200858 | Mini Sterilizable Tray | Implant Direct Sybron Manufacturing, LLC | 2020 | 1 |
| −1 | K202524 | Standard Sterilizable Tray | Implant Direct Sybron Manufacturing, LLC | 2021 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K202524 | Standard Sterilizable TraySummary page 5…KCT Legally Marketed Predicate Device Predicate Device Name Standard Sterilizable Tray 510(k) Number: K202524 Product Code: KCT Regulation Number: 21 CFR § 880.6850 Devi… | 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 41 years and passes through 8 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K202524.
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. 2025, 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 Sterilization Trays are designed to hold various dental surgical and prosthetic instruments to organize, steam sterilize and transport the instruments between uses. The kit is to be enclosed in an FDA cleared steam sterilizable pouch large enough to fit a tray, and sterilized in an FDA cleared sterilizer for the following cycles:
1. Gravity Steam Cycle — At 132°C for 15 minutes with a 30-minute dry time
2. Pre-vacuum Steam Cycle — At 132°C for 4 minutes with a 20-minute dry time
* The kits are intended for sterilization of non-porous loads
* The tested kit represents the worst-case validated load of 497.1 grams
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/K251756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251756: Sterilization Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251756
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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