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 Corporation · FRG Wrap, Sterilization
Cleared on Jun 6, 2018 as substantially equivalent to K133838 (Sigma Medical Supplies Corp., 2015) after an 84-day review. Its family tree reaches back 3 generations to 1993. 9 later devices descend from it.
- Decided
- Jun 6, 2018
- Review
- 84 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921910 (1993). 4 ancestors in all. 9 later devices descend from it, 4 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 backK133838 Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corp. · 2015
- This deviceK180672 Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation · 2018
- Descendant · cites it directly · 3 of its ownK212198 Tyvek (R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK221379 Steriking LT-Blueline Pouches with TyvekWipak OY · 2023
- Descendant · cites it directly · 1 of its ownK221377 SteriKing LT-Blueline Pouches with TyvekWipak OY · 2022
- Descendant · cites it directly · 0 of its ownK241123 Perpak™ Sterilization Tyvek PouchKm Corp. · 2024
- Descendant · 2 generations on · 0 of its ownK231999 Steriking® LT-Blueline Pouches with Tyvek®Wipak OY · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K212198Tyvek (R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd. · 2021 · cites it directly3descendants
- K221379Steriking LT-Blueline Pouches with TyvekWipak OY · 2023 · cites it directly1descendant
- K221377SteriKing LT-Blueline Pouches with TyvekWipak OY · 2022 · cites it directly1descendant
- K241123Perpak™ Sterilization Tyvek PouchKm Corp. · 2024 · cites it directly0descendants
- K231999Steriking® LT-Blueline Pouches with Tyvek®Wipak OY · 2023 · 2 generations on0descendants
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 | K133838 | Sterilization Pouch/Roll Made with Tyvek | Sigma Medical Supplies Corp. | 2015 | — |
| 0 (this device) | K180672 | Sterilization Pouch/Roll Made with Tyvek | Sigma Medical Supplies Corporation | 2018 | — |
| +1 | K212198 | Tyvek (R) Roll with CI for STERLINKTM Sterilizer | Plasmapp Co,., Ltd. | 2021 | — |
| +1 | K221379 | Steriking LT-Blueline Pouches with Tyvek | Wipak OY | 2023 | — |
| +1 | K221377 | SteriKing LT-Blueline Pouches with Tyvek | Wipak OY | 2022 | — |
| +1 | K241123 | Perpak™ Sterilization Tyvek Pouch | Km Corp. | 2024 | — |
| +2 | K231999 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K133838 | Sterilization Pouch/Roll Made with TyvekSummary page 4…Regulation Number: 1) 21 CFR 880.6850 2) 21 CFR 880.2800 5.3 Predicate Devices: The predicate device [510(k) Notification K133838, cleared March 11, 2015] is the Sterilization Pouch/Roll Made with Tyvek® Manufacturer：SIGMA Medical Supplies Corp. Product… | 2015 |
What descends from it? (9)
4 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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K212198 (Plasmapp Co,., Ltd., 2021) has gone furthest, with 3 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. 2018, 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® 100S Sterilizer.
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 as stated in the FDA summary.
https://510kreport.com/device/K180672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180672: 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/K180672
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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