510(k) · Cleared
ClearedSterilization Pouch/Roll Made with Tyvek
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Medical Supplies Corp. · FRG Wrap, Sterilization
Cleared on Mar 11, 2015 as substantially equivalent to K103210 (Advanced Sterilization Products, 2011) after a 448-day review. Its family tree reaches back 2 generations to 1993. 10 later devices descend from it.
- Decided
- Mar 11, 2015
- Review
- 448 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921910 (1993). 3 ancestors in all. 10 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 deviceK133838 Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corp. · 2015
- Descendant · cites it directly · 9 of its ownK180672 Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation · 2018
- Descendant · 2 generations on · 3 of its ownK212198 Tyvek (R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK221379 Steriking LT-Blueline Pouches with TyvekWipak OY · 2023
- Descendant · 2 generations on · 1 of its ownK221377 SteriKing LT-Blueline Pouches with TyvekWipak OY · 2022
- Descendant · 2 generations on · 0 of its ownK241123 Perpak™ Sterilization Tyvek PouchKm Corp. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K180672Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation · 2018 · cites it directly9descendants
- K212198Tyvek (R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd. · 2021 · 2 generations on3descendants
- K221379Steriking LT-Blueline Pouches with TyvekWipak OY · 2023 · 2 generations on1descendant
- K221377SteriKing LT-Blueline Pouches with TyvekWipak OY · 2022 · 2 generations on1descendant
- K241123Perpak™ Sterilization Tyvek PouchKm Corp. · 2024 · 2 generations on0descendants
View 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) | K133838 | Sterilization Pouch/Roll Made with Tyvek | Sigma Medical Supplies Corp. | 2015 | — |
| +1 | K180672 | Sterilization Pouch/Roll Made with Tyvek | Sigma Medical Supplies Corporation | 2018 | — |
| +2 | K212198 | Tyvek (R) Roll with CI for STERLINKTM Sterilizer | Plasmapp Co,., Ltd. | 2021 | — |
| +2 | K221379 | Steriking LT-Blueline Pouches with Tyvek | Wipak OY | 2023 | — |
| +2 | K221377 | SteriKing LT-Blueline Pouches with Tyvek | Wipak OY | 2022 | — |
| +2 | K241123 | Perpak™ Sterilization Tyvek Pouch | Km Corp. | 2024 | — |
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 |
|---|---|---|
| 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? (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 6…General Hospital Product Code: FRG Recognized Performance ANSI/AAMI/ISO 11607-1:2006 (FRG) Standard: 5.4 Predicate Devices: K103210, Tyvek® Pouch/Roll with STERRAD® Chemical Indicator (FRG) SIGMA MEDICAL SUPPLIES CORP.… | 2011 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180672 | Sterilization Pouch/Roll Made with Tyvek | 2018 | 9 |
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 22 years and passes through 3 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, K180672 (Sigma Medical Supplies Corporation, 2018) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K103210.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO…
Read the full statement (127 words)
The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.
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 blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.
The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:
z Self-sealing sterilization pouches
z Sterilization pouches, Flat
z Sterilization pouches, Gusseted
z Sterilization rolls, Flat
z Sterilization rolls, Gusseted
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/K133838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133838: Sterilization Pouch/Roll Made with Tyvek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133838
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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