510(k) · Cleared
ClearedPolyvac Surgical Instrument Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Symmetry Medical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Aug 2, 2002 as substantially equivalent to K944025 (Riley Medical, Inc., 1994) and 2 other predicates after a 393-day review. Its family tree reaches back 3 generations to 1984. 1 of the 155 devices in its family, counting itself, has a Class I recall. 149 later devices descend from it.
- Decided
- Aug 2, 2002
- Review
- 393 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K844002 (1984). 5 ancestors in all. 149 later devices descend from it, 21 citing it directly. 1 of the 155 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 2 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 1 generation backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- This deviceK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- Descendant · cites it directly · 58 of its ownK033222 Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004
- Descendant · cites it directly · 46 of its ownK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- Descendant · cites it directly · 43 of its ownK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- Descendant · 2 generations on · 42 of its ownK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- Descendant · cites it directly · 30 of its ownK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
Showing 5 of 149 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K050220 Evis Exera Bronchovideoscope, Olympus…2 generations on · 2005
Most influential descendants
Showing 5 of 149 · See all- K033222Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004 · cites it directly58descendants
- K040223Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004 · cites it directly46descendants
- K023658Sterilization Cases and TraysCarr Metal Products, Inc. · 2003 · cites it directly43descendants
- K052992Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006 · 2 generations on42descendants
- K142519InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015 · cites it directly30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −2 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −1 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| 0 (this device) | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| +1 | K033222 | Olympus Sterilization Trays | Olympus Winter & Ibe GmbH | 2004 | — |
| +1 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 1 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 15 | 0 |
| 2020 | 10 | 0 |
| 2021 | 19 | 0 |
| 2022 | 9 | 0 |
| 2023 | 10 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K944025 | Surgical Instrument TraySummary page 3…ped packages. Substantial Equivalence: The Delivery Systems offered by PolyVac are comparable in design to sterilization cases and trays manufactured by Riley Medical #K944025 (primary predicate). Additionally, sterilization cases and trays are also offered by: Tuttnauer USA #K99076… | 1994 |
| * | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteSummary page 3…nd trays manufactured by Riley Medical #K944025 (primary predicate). Additionally, sterilization cases and trays are also offered by: Tuttnauer USA #K99076 1 C/T Medical Systems #K980065 Conclusions: The studies conducted on PolyVac's Delivery Systems demonstrate that the… | 1999 |
| * | K980065 | C/T Med-Systems Cassette SystemSummary page 3…4025 (primary predicate). Additionally, sterilization cases and trays are also offered by: Tuttnauer USA #K99076 1 C/T Medical Systems #K980065 Conclusions: The studies conducted on PolyVac's Delivery Systems demonstrate that the device is substantially equivalent to oth… | 1998 |
What descends from it? (149)
See all 14921 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033222 | Olympus Sterilization Trays | 2004 | 58 |
| K040223 | Polyvac Instrument Delivery System | 2004 | 46 |
| K023658 | Sterilization Cases and Trays | 2003 | 43 |
| K142519 | InterActive Complete Surgical Tray | 2015 | 30 |
| K131455 | Restore Modular Sterilization Tray System | 2013 | 30 |
| K120947 | THS Instrument Tray | 2012 | 30 |
| K032119 | Paragon Medical Surgical Instrument Delivery System Various | 2003 | 18 |
| K073551 | Smith & Nephew Instrument Trays | 2008 | 13 |
| K072211 | Intuitive Surgical Instrument and Accessories Sterilization Trays | 2008 | 7 |
| K130532 | Idrive Ultra Sterilization Tray | 2013 | 6 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation · 2005 · 2 generations on · ◆ in the 2005 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K033222 (Olympus Winter & Ibe GmbH, 2004) has gone furthest, with 58 descendants of its own.
- 3 other devices also cite its predicate K944025.
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 steam penetration and air removal. When used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device is maintained until used.
PolyVac's delivery systems are to be sterilized in one of the following cycles:
Prevacuum Steam : 132°C - 4 minutes minimum
Gravity Steam: 132°C - 30 minutes minimum
Gravity Steam: 121°C - 55 minutes minimum
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012105: Polyvac Surgical Instrument Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012105
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026