510(k) · Cleared
ClearedPolyvac Instrument Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Symmetry Medical USA, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Oct 22, 2004 as substantially equivalent to K012105 (Symmetry Medical, Inc., 2002) and 2 other predicates after a 263-day review. Its family tree reaches back 4 generations to 1984. 46 later devices descend from it.
- Decided
- Oct 22, 2004
- Review
- 263 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K844002 (1984). 8 ancestors in all. 46 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 3 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 2 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 1 generation backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- This deviceK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- Descendant · cites it directly · 30 of its ownK131455 Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc. · 2013
- Descendant · cites it directly · 30 of its ownK120947 THS Instrument TrayHologic, Inc. · 2012
- Descendant · 2 generations on · 29 of its ownK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- Descendant · 3 generations on · 18 of its ownK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- Descendant · 4 generations on · 11 of its ownK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K131455Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc. · 2013 · cites it directly30descendants
- K120947THS Instrument TrayHologic, Inc. · 2012 · cites it directly30descendants
- K152241Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016 · 2 generations on29descendants
- K163600Kit Boxes and Kit PlatesNobel Biocare AB · 2018 · 3 generations on18descendants
- K180791Straumann BLX Surgical CassetteInstitut Straumann AG · 2018 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −3 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −2 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −1 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| 0 (this device) | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| +1 | K131455 | Restore Modular Sterilization Tray System | Restore Medical Solutions, Inc. | 2013 | — |
| +1 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| +2 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| +3 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| +4 | K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 8 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 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? (3)
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 3…Equivalence: The Delivery Systems offered by PolyVac are of the same design as sterilization cases and trays manufactured by PolyVac under a previously cleared 510(k) - K012105. The devices are substantially equivalent to other sterilization cases cleared for use with Ethylene Oxide: Aptimax - K013003, Ad… | 2002 |
| * | K013003 | Aptimax Instrument Tray, Instrument Mat and Instrument HolderSummary page 3…PolyVac under a previously cleared 510(k) - K012105. The devices are substantially equivalent to other sterilization cases cleared for use with Ethylene Oxide: Aptimax - K013003, Advanced Sterilization Products, and Metapak - K993535, Riley Medical, Inc. Conclusions:… | 2002 |
| * | K993535 | Metapak Multi-Purpose Instrument TraySummary page 3…devices are substantially equivalent to other sterilization cases cleared for use with Ethylene Oxide: Aptimax - K013003, Advanced Sterilization Products, and Metapak - K993535, Riley Medical, Inc. Conclusions: the The studies… | 2001 |
What descends from it? (46)
See all 467 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131455 | Restore Modular Sterilization Tray System | 2013 | 30 |
| K120947 | THS Instrument Tray | 2012 | 30 |
| K092682 | Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays | 2009 | 5 |
| K081939 | Omniguide Beampath Fiber Optic Handpiece System and Sterilization Tray | 2008 | 4 |
| K121280 | Myosure Intrument Tray | 2013 | 1 |
| K102970 | Gyrus Acmi Cyber Wand-Sterilization Trays Model FGT | 2011 | 0 |
| K091806 | Pogo Screw Instrumentation Tray | 2010 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K131455 (Restore Medical Solutions, Inc., 2013) has gone furthest, with 30 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.
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?
PolyVac's delivery systems consist of perforated trays with lids, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing sterilant penetration and air removal, When used in conjunction with an approved sterilization wrap.
Sterilization Method: Ethylene Oxide
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040223 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040223: Polyvac Instrument Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040223
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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