510(k) · Cleared
ClearedTyvek Self-Seal Pouches ,Tyvek Heat-Seal Rolls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Oct 15, 2012 as substantially equivalent to K103210 (Advanced Sterilization Products, 2011) after a 452-day review. Its family tree reaches back 2 generations to 1993. 2 later devices descend from it.
- Decided
- Oct 15, 2012
- Review
- 452 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921910 (1993). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 1 generation backK103210 Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad…Advanced Sterilization Products · 2011
- This deviceK112087 Tyvek Self-Seal Pouches ,Tyvek Heat-Seal RollsAdvanced Sterilization Products · 2012
- Descendant · cites it directly · 1 of its ownK141693 Tyvek® Pouch/Roll with STERRAD® Chemical IndicatorAdvanced Sterilization Products · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK163598 Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls…Advanced Sterilization Products · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −1 | K103210 | Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek… | Advanced Sterilization Products | 2011 | — |
| 0 (this device) | K112087 | Tyvek Self-Seal Pouches ,Tyvek Heat-Seal Rolls | Advanced Sterilization Products | 2012 | — |
| +1 | K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | Advanced Sterilization Products | 2014 | 1 |
| +2 | K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with… | Advanced Sterilization Products | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K103210 | Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with…Summary page 1…cal Indicator, which is currently manufactured and distributed by Advanced Sterilization Products [5 10(k) Notification K 1032 10, cleared June 6, 2011] 3. INDICATIONS FOR USE Tyvek® Pouches and Rolls with STERJ{ADO… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | 2014 | 1 |
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 19 years and passes through 2 companies; a new generation was cleared every 17.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K141693 (Advanced Sterilization Products, 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K103210.
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. 2012, 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?
Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® 100N-X® Sterilizer and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll maintains sterility until the seal of the pouch/roll is opened; in the United States, this is for a period of 30 days.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112087: Tyvek Self-Seal Pouches ,Tyvek Heat-Seal Rolls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112087
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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