510(k) · Cleared
ClearedSterisystem Dry-Base Instrument Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O&M Halyard, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jan 2, 2022 as substantially equivalent to K102122 (Smith & Nephew, Inc., 2010) after a 433-day review. Its family tree reaches back 8 generations to 1984.
- Decided
- Jan 2, 2022
- Review
- 433 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K844002 (1984). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 7 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 6 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 5 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 4 generations backK073551 Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div. · 2008
- 3 generations backK090562 Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009
- 2 generations backK091627 Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009
- 1 generation backK102122 Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428Smith & Nephew, Inc. · 2010
- This deviceK203177 Sterisystem Dry-Base Instrument TrayO&M Halyard, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −7 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −6 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −5 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −4 | K073551 | Smith & Nephew Instrument Trays | Smith & Nephew Inc., Endoscopy Div. | 2008 | — |
| −3 | K090562 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | 2009 | — |
| −2 | K091627 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | 2009 | — |
| −1 | K102122 | Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428 | Smith & Nephew, Inc. | 2010 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K102122 | Smith & Nephew Milti-Purpose Sterilization Tray Model 72202428Summary page 5…t Code KCT and Classification Name: Class II, 21 CFR §880.6850 Predicate Device: Smith & Nephew Multi Purpose Instrument Tray (K102122) Subject Device Description: The Sterisystem Dry-Base Instrument Trays are reusable sterilization trays.… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- None of the 11 ancestors has a recall.
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. 2022, 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 Sterisystem Dry-Base Instrument Tray are intended to protect medical device instrumentation and facilitate the sterilization process by sterilant penetration and air removal. When used in conjunction with an FDA cleared sterilization wrap, sterility of the enclosed medical device is maintained until used. The system has been validated for the use in the following sterilization cycle: Pre-Vacuum Steam Temperature 132oC (270oF) Sterilization Time 4…
Read the full statement (108 words)
The Sterisystem Dry-Base Instrument Tray are intended to protect medical device instrumentation and facilitate the sterilization process by sterilant penetration and air removal. When used in conjunction with an FDA cleared sterilization wrap, sterility of the enclosed medical device is maintained until used.
The system has been validated for the use in the following sterilization cycle:
Pre-Vacuum Steam
Temperature 132oC (270oF)
Sterilization Time 4 minutes
Drying time 30
Maximum Tray Weight Up to 25lbs depending on the weight limit of the cleared sterilization wrap used.
Pre-Vacuum sterilized devices may be stored in a protective storage for up to 30 days provided integrity of the container is not comprised.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203177: Sterisystem Dry-Base Instrument Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203177
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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