510(k) · Cleared
ClearedInterActive Complete Surgical 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 Apr 15, 2015 as substantially equivalent to K052992 (Conmed Linvatec, 2006) and 3 other predicates after a 219-day review. Its family tree reaches back 6 generations to 1984. 30 later devices descend from it.
- Decided
- Apr 15, 2015
- Review
- 219 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K844002 (1984). 9 ancestors in all. 30 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 4 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 3 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 2 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 1 generation backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- This deviceK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- Descendant · cites it directly · 20 of its ownK160730 Instrument kitsAnthogyr · 2017
- Descendant · 2 generations on · 18 of its ownK171713 Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018
- Descendant · 3 generations on · 13 of its ownK182865 Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- Descendant · 4 generations on · 5 of its ownK192670 Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
- Descendant · 4 generations on · 4 of its ownK201688 S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A. · 2020
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K160730Instrument kitsAnthogyr · 2017 · cites it directly20descendants
- K171713Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018 · 2 generations on18descendants
- K182865Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019 · 3 generations on13descendants
- K192670Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019 · 4 generations on5descendants
- K201688S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −5 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −4 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −3 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −2 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −1 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| 0 (this device) | K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| +1 | K160730 | Instrument kits | Anthogyr | 2017 | — |
| +2 | K171713 | Neodent Instrument Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018 | — |
| +3 | K182865 | Neodent Instruments Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019 | — |
| +4 | K192670 | Neodent Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019 | — |
| +4 | K201688 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | 2020 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K052992 | Conmed Linvatec Instrument Sterilization TraySummary page 5…plete Surgical Tray Traditional 510(K) Submission 3. Predicate Devices Conmed Linvatech Instrument Sterilization Tray (K052992) Polyvac Inc. Surgical Instrument Delivery Tray (K012105) Tuttnauer USA Co Ltd. Cassette Container (K990761) C/T Medi… | 2006 |
| * | K012105 | Polyvac Surgical Instrument Delivery SystemSummary page 5…Traditional 510(K) Submission 3. Predicate Devices Conmed Linvatech Instrument Sterilization Tray (K052992) Polyvac Inc. Surgical Instrument Delivery Tray (K012105) Tuttnauer USA Co Ltd. Cassette Container (K990761) C/T Medical Systems Sterilization Cassettes (K980065) 4. Descripti… | 2002 |
| * | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteSummary page 5…s Conmed Linvatech Instrument Sterilization Tray (K052992) Polyvac Inc. Surgical Instrument Delivery Tray (K012105) Tuttnauer USA Co Ltd. Cassette Container (K990761) C/T Medical Systems Sterilization Cassettes (K980065) 4. Description of Device The InterActive Complete Surgical Tray… | 1999 |
| * | K980065 | C/T Med-Systems Cassette SystemSummary page 5…992) Polyvac Inc. Surgical Instrument Delivery Tray (K012105) Tuttnauer USA Co Ltd. Cassette Container (K990761) C/T Medical Systems Sterilization Cassettes (K980065) 4. Description of Device The InterActive Complete Surgical Tray is a reusable rigid sterilization container or organi… | 1998 |
What descends from it? (30)
See all 305 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 31 years and passes through 7 companies; a new generation was cleared every 3.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K160730 (Anthogyr, 2017) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K052992.
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. 2015, 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 InterActive Complete Surgical Tray is designed to hold various dental surgical drills and tools 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: (1) Prevaccum Steam – At 1320C for 4 minutes with a 20 minutes dry time. (2) Gravity Steam - At 1320C for 15 minutes with a 30…
Read the full statement (182 words)
The InterActive Complete Surgical Tray is designed to hold various dental surgical drills and tools 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:
(1) Prevaccum Steam – At 1320C for 4 minutes with a 20 minutes dry time.
(2) Gravity Steam - At 1320C for 15 minutes with a 30 minutes dry time.
- The trays are intended for sterilization of non-porous loads.
- The trays are recommended not to be stacked during sterilization.
- The Complete Surgical Tray represents the worst case validated load due to the number of components (45 instruments)
and the weight of 608.05 grams.
- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Interactive Complete Surgical Tray.
- The tray will be marketed in following variations.
Device Model Name Max no. of Instruments Weight of each tray
with instruments (gms.)
CST 45 608.05
ICST 34 467.26
IBST 18 453.59
IST 0 404.37
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142519: InterActive Complete Surgical Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142519
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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