510(k) · Cleared
Recalled · Class II · 2014Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products · FRG Wrap, Sterilization
Cleared on Dec 19, 2014 as substantially equivalent to K112087 (Advanced Sterilization Products, 2012) after a 178-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 19, 2014
- Review
- 178 days
- Class
- Class II
- Product code
- FRG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921910 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 2 generations backK103210 Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad…Advanced Sterilization Products · 2011
- 1 generation backK112087 Tyvek Self-Seal Pouches ,Tyvek Heat-Seal RollsAdvanced Sterilization Products · 2012
- This deviceK141693 Tyvek® Pouch/Roll with STERRAD® Chemical IndicatorAdvanced Sterilization Products · 2014
- Descendant · cites it directly · 0 of its ownK163598 Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls…Advanced Sterilization Products · 2017
Most influential descendants
Showing 1 of 1 · See all- K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD…Advanced Sterilization Products · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −2 | K103210 | Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek… | Advanced Sterilization Products | 2011 | — |
| −1 | K112087 | Tyvek Self-Seal Pouches ,Tyvek Heat-Seal Rolls | Advanced Sterilization Products | 2012 | — |
| 0 (this device) | K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator | Advanced Sterilization Products | 2014 | — |
| +1 | 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 |
|---|---|---|
| 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 FRG? 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 FRG device
- #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 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 |
|---|---|---|---|
| * | K112087 | Tyvek Self-Seal Pouches ,Tyvek Heat-Seal RollsSummary page 5…21 CFR 880.2800 Proprietary Name: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator 2. PREDICATE DEVICES The predicate device [510(k) Notification K112087, cleared October 15, 2012] is the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator, for use in the STERRAD® 100NX® Steril… | 2012 |
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 |
|---|---|---|---|
| K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD… | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 24, 2014 | Class II | Z-1312-2015 | Under Investigation by firm | Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K163598 (Advanced Sterilization Products, 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FRG
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 2025
MAUDE reports naming product code FRG, 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 | 182 | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 4 | 171 | 0 | 2 |
| 2010 | 4 | 213 | 0 | 0 |
| 2011 | 6 | 110 | 0 | 12 |
| 2012 | 10 | 133 | 0 | 4 |
| 2013 | 6 | 146 | 2 | 5 |
| 2014 | 8 | 177 | 0 | 13 |
| 2015 | 12 | 196 | 0 | 9 |
| 2016 | 9 | 131 | 0 | 20 |
| 2017 | 9 | 260 | 29 | 7 |
| 2018 | 5 | 150 | 0 | 22 |
| 2019 | 9 | 258 | 0 | 10 |
| 2020 | 5 | 122 | 14 | 21 |
| 2021 | 4 | 170 | 0 | 9 |
| 2022 | 9 | 217 | 2 | 4 |
| 2023 | 9 | 230 | 0 | 13 |
| 2024 | 11 | 182 | 0 | 21 |
| 2025 | 9 | 151 | 0 | 18 |
| 2026 | 4 | 247 | 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® Sterilization Systems and Cycles, in a single or double pouch configuration, 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 pouch/roll is used; in the United States, this…
Read the full statement (150 words)
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® Sterilization Systems and Cycles, in a single or double pouch configuration, 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 pouch/roll is used; in the United States, this is for a period of 30 days.
The STERRAD® Sterilization Systems and Cycles that can be used are shown in Table 1. The product codes for all Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are listed in Table 2.
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/K141693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141693: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141693
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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