510(k) · Cleared
ClearedSmith & Nephew Milti-Purpose Sterilization Tray Model 72202428
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 Nov 22, 2010 as substantially equivalent to K073551 (Smith & Nephew Inc., Endoscopy Div., 2008) and 2 other predicates after a 116-day review. Its family tree reaches back 7 generations to 1984. 1 later device descends from it.
- Decided
- Nov 22, 2010
- Review
- 116 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K844002 (1984). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 5 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 4 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 3 generations backK073551 Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div. · 2008
- 2 generations backK090562 Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009
- 1 generation backK091627 Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009
- This deviceK102122 Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428Smith & Nephew, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK203177 Sterisystem Dry-Base Instrument TrayO&M Halyard, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K203177Sterisystem Dry-Base Instrument TrayO&M Halyard, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −6 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −5 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −4 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −3 | K073551 | Smith & Nephew Instrument Trays | Smith & Nephew Inc., Endoscopy Div. | 2008 | — |
| −2 | K090562 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | 2009 | — |
| −1 | K091627 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | 2009 | — |
| 0 (this device) | K102122 | Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428 | Smith & Nephew, Inc. | 2010 | — |
| +1 | K203177 | Sterisystem Dry-Base Instrument Tray | O&M Halyard, Inc. | 2022 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K073551 | Smith & Nephew Instrument TraysSummary page 1…Trays are substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: K073551: Tray - ACUFEX Tm DIRECTOR ELITE Drill Guide Systems K090562: Tray - ELITE Premium Biceps Tenodesis System K091627: Tray… | 2008 |
| * | K090562 | Smith & Nephew Instrument TraysSummary page 1…ental Scientific Technology to the following legally marketed device in commercial distribution: K073551: Tray - ACUFEX Tm DIRECTOR ELITE Drill Guide Systems K090562: Tray - ELITE Premium Biceps Tenodesis System K091627: Tray - ELITE Premium Instability System Smith & Nephew, Inc.… | 2009 |
| * | K091627 | Smith & Nephew Instrument TraysSummary page 1…ted device in commercial distribution: K073551: Tray - ACUFEX Tm DIRECTOR ELITE Drill Guide Systems K090562: Tray - ELITE Premium Biceps Tenodesis System K091627: Tray - ELITE Premium Instability System Smith & Nephew, Inc. Page 1 of 2 Speci… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203177 | Sterisystem Dry-Base Instrument Tray | 2022 | 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 26 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K203177 (O&M Halyard, Inc., 2022) has gone furthest, with 0 descendants 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. 2010, 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 Multi-Purpose Sterilization 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 sterilization method. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
Method Temperature Exposure Time Drying Time
Pre-vacuum 132 C 4 minutes 30 minutes
steam (270 F)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102122: Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102122
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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