510(k) · Cleared
ClearedRestore Modular Sterilization Tray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restore Medical Solutions, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Aug 30, 2013 as substantially equivalent to K012105 (Symmetry Medical, Inc., 2002) and 1 other predicate after a 102-day review. Its family tree reaches back 5 generations to 1984. 30 later devices descend from it.
- Decided
- Aug 30, 2013
- Review
- 102 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 deviceK131455 Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc. · 2013
- 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) | K131455 | Restore Modular Sterilization Tray System | Restore Medical Solutions, Inc. | 2013 | — |
| +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…and Accessories Name: Classification Class Class 11 and Regulation 21 CFR 880.6850 Number: Product Code: KCT Predicate K012105, PolyVac Inc., PolyVac Surgical Instrument Delivery Device(s): System K040223, Symm… | 2002 |
| * | K040223 | Polyvac Instrument Delivery SystemSummary page 1…e: KCT Predicate K012105, PolyVac Inc., PolyVac Surgical Instrument Delivery Device(s): System K040223, Symmetry Medical Inc., PolyVac Surgical Instrument Delivery System Statement of The… | 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 29 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. 2013, 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 Restore™ Modular Sterilization Tray System is intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other Instrumentation between surgical and other medical uses when used In conjunction with a FDA cleared sterilization wrap. The Modular Sterilization Tray System may be used with common surgical Instruments such as hammers, rasps, drivers, chisels, ringed-handled instruments, rongeurs…
Read the full statement (152 words)
The Restore™ Modular Sterilization Tray System is intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other Instrumentation between surgical and other medical uses when used In conjunction with a FDA cleared sterilization wrap.
The Modular Sterilization Tray System may be used with common surgical Instruments such as hammers, rasps, drivers, chisels, ringed-handled instruments, rongeurs, pickups, including but not limited to short-lumened devices etc. The validated total weight for tray and contents was 20 pounds.
Reusable Medical Device Challenge Conditions
Minimum Inner Diameter: 1.8 mm; Maximum Length: 4 inches; Number of lumens: 2
High Vacuum (pre-vacuum, three pulse, standard):
Temp: 270°F
Exposure Time: 4 Minutes
Cycle Dry Time (wrapped): 20 Minutes (minimum)
Cool Time: Varies according to toad contents
NOTE: Cool drafts from air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization moisture caused by rapid cooling syndrome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131455: Restore Modular Sterilization Tray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131455
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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