510(k) · Cleared
ClearedTyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with Sterrad Chemical Indicators
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 Jun 6, 2011 as substantially equivalent to K951295 (Advanced Sterilization Products, 1995) and 1 other predicate after a 217-day review. Its family tree reaches back 1 generation to 1993. 15 later devices descend from it.
- Decided
- Jun 6, 2011
- Review
- 217 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921910 (1993). 2 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- This deviceK103210 Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad…Advanced Sterilization Products · 2011
- Descendant · cites it directly · 10 of its ownK133838 Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corp. · 2015
- Descendant · 2 generations on · 9 of its ownK180672 Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation · 2018
- Descendant · 3 generations on · 3 of its ownK212198 Tyvek (R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK112087 Tyvek Self-Seal Pouches ,Tyvek Heat-Seal RollsAdvanced Sterilization Products · 2012
- Descendant · 3 generations on · 1 of its ownK221379 Steriking LT-Blueline Pouches with TyvekWipak OY · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K133838Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corp. · 2015 · cites it directly10descendants
- K180672Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation · 2018 · 2 generations on9descendants
- K212198Tyvek (R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd. · 2021 · 3 generations on3descendants
- K112087Tyvek Self-Seal Pouches ,Tyvek Heat-Seal RollsAdvanced Sterilization Products · 2012 · cites it directly2descendants
- K221379Steriking LT-Blueline Pouches with TyvekWipak OY · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| 0 (this device) | K103210 | Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek… | Advanced Sterilization Products | 2011 | — |
| +1 | K133838 | Sterilization Pouch/Roll Made with Tyvek | Sigma Medical Supplies Corp. | 2015 | — |
| +2 | K180672 | Sterilization Pouch/Roll Made with Tyvek | Sigma Medical Supplies Corporation | 2018 | — |
| +3 | K212198 | Tyvek (R) Roll with CI for STERLINKTM Sterilizer | Plasmapp Co,., Ltd. | 2021 | — |
| +1 | K112087 | Tyvek Self-Seal Pouches ,Tyvek Heat-Seal Rolls | Advanced Sterilization Products | 2012 | — |
| +3 | K221379 | Steriking LT-Blueline Pouches with Tyvek | Wipak OY | 2023 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K951295 | Sterrad Sterilization PouchSummary page 1…cator 2. PREDICATE DEVICES STERRAD® Sterilization Pouch, which is currently manufactured and distributed by Advanced Sterilization Products [5 10(k) Notification K95 1295, cleared May 19, 1995]. STERRAD® Chemical Indicator Strip, which is currently manufactured and distributed by Advanced… | 1995 |
| * | K921910 | Sterrad Chemical IndicatorSummary page 1…eared May 19, 1995]. STERRAD® Chemical Indicator Strip, which is currently manufactured and distributed by Advanced Sterilization Products [510(k) Notification K921910, cleared October 4, 1993]. 3. INDICATIONS FOR USE Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended… | 1993 |
What descends from it? (15)
See all 153 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?
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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® 100NX™ 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.
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/K103210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103210: Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with Sterrad Chemical Indicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103210
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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