510(k) · Cleared
ClearedSmith & Nephew Instrument Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jul 2, 2009 as substantially equivalent to K073551 (Smith & Nephew Inc., Endoscopy Div., 2008) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 1984. 4 later devices descend from it.
- Decided
- Jul 2, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K844002 (1984). 9 ancestors in all. 4 later devices descend from it, 3 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 backK073551 Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div. · 2008
- 1 generation backK090562 Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009
- This deviceK091627 Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK102122 Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428Smith & Nephew, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK203177 Sterisystem Dry-Base Instrument TrayO&M Halyard, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK102544 Smith & Nephew Hip Arthroscopy Repair Instrument TraySmith & Nephew Inc., Endoscopy Div. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK092551 Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div. · 2010
Most influential descendants
Showing 4 of 4 · See all- K102122Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428Smith & Nephew, Inc. · 2010 · cites it directly1descendant
- K203177Sterisystem Dry-Base Instrument TrayO&M Halyard, Inc. · 2022 · 2 generations on0descendants
- K102544Smith & Nephew Hip Arthroscopy Repair Instrument TraySmith & Nephew Inc., Endoscopy Div. · 2011 · cites it directly0descendants
- K092551Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div. · 2010 · cites it directly0descendants
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 | K073551 | Smith & Nephew Instrument Trays | Smith & Nephew Inc., Endoscopy Div. | 2008 | — |
| −1 | K090562 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | 2009 | — |
| 0 (this device) | K091627 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | 2009 | — |
| +1 | K102122 | Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428 | Smith & Nephew, Inc. | 2010 | — |
| +2 | K203177 | Sterisystem Dry-Base Instrument Tray | O&M Halyard, Inc. | 2022 | — |
| +1 | K102544 | Smith & Nephew Hip Arthroscopy Repair Instrument Tray | Smith & Nephew Inc., Endoscopy Div. | 2011 | 1 |
| +1 | K092551 | Smith & Nephew Instrument Trays | Smith & Nephew Inc., Endoscopy Div. | 2010 | — |
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 |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K073551 | Smith & Nephew Instrument TraysSummary page 1…ded Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew Instrument Tray cleared under K073551 and Smith & Nephew Instrument Trays cleared under K090562. E. Description of Device The Smith & Nephew instrument tr… | 2008 |
| * | K090562 | Smith & Nephew Instrument TraysSummary page 1…wing legally marketed device in commercial distribution: Smith & Nephew Instrument Tray cleared under K073551 and Smith & Nephew Instrument Trays cleared under K090562. E. Description of Device The Smith & Nephew instrument trays are designed to contain and protect reusable surgical… | 2009 |
What descends from it? (4)
3 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 25 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, K102122 (Smith & Nephew, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K073551.
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. 2009, 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?
Smith & Nephew instrument trays are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument trays are suitable for use in prevacuum steam and high temperature gravity steam sterilization methods. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated sterilization wrap in…
Read the full statement (101 words)
Smith & Nephew instrument trays are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument trays are suitable for use in prevacuum steam and high temperature gravity steam sterilization methods. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
Method Temperature Exposure Time Drying Time
Pre-vacuum steam 132C (270F) 4 minutes 30 minutes
High Temperature Gravity Steam 132C (270F) 15 minutes 70 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091627 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091627: Smith & Nephew Instrument Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091627
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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