510(k) · Cleared
ClearedTyvek (R) Roll with CI for STERLINKTM Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plasmapp Co,., Ltd. · FRG Wrap, Sterilization
Cleared on Oct 22, 2021 as substantially equivalent to K180672 (Sigma Medical Supplies Corporation, 2018) after a 100-day review. Its family tree reaches back 4 generations to 1993. 3 later devices descend from it.
- Decided
- Oct 22, 2021
- Review
- 100 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921910 (1993). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 3 generations backK103210 Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad…Advanced Sterilization Products · 2011
- 2 generations backK133838 Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corp. · 2015
- 1 generation backK180672 Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation · 2018
- This deviceK212198 Tyvek (R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK231169 STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI…Plasmapp Co,., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223025 Tyvek Roll with CI for STERLINK SterilizerPlasmapp Co,., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK220345 STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll…Plasmapp Co,., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd. · 2023 · cites it directly0descendants
- K223025Tyvek Roll with CI for STERLINK SterilizerPlasmapp Co,., Ltd. · 2023 · cites it directly0descendants
- K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −3 | K103210 | Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek… | Advanced Sterilization Products | 2011 | — |
| −2 | 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 | — |
| 0 (this device) | K212198 | Tyvek (R) Roll with CI for STERLINKTM Sterilizer | Plasmapp Co,., Ltd. | 2021 | — |
| +1 | K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for… | Plasmapp Co,., Ltd. | 2023 | — |
| +1 | K223025 | Tyvek Roll with CI for STERLINK Sterilizer | Plasmapp Co,., Ltd. | 2023 | — |
| +1 | K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for… | Plasmapp Co,., Ltd. | 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 |
|---|---|---|
| 2023 | 3 | 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 |
|---|---|---|---|
| * | K180672 | Sterilization Pouch/Roll Made with TyvekSummary page 6…uch/Roll Made with Tyvek® Sterilizer 510(k) Number K212198 K180672 Device Classification 1) Sterilization Wrap… | 2018 |
What descends from it? (3)
3 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 28 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K231169 (Plasmapp Co,., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K180672.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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® Roll with CI for STERLINK™ Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization. The maximum load weight that can be placed in the Tyvek® roll is 3.97 pounds…
Read the full statement (131 words)
Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.
The maximum load weight that can be placed in the Tyvek® roll is 3.97 pounds (1.8kg).
The roll is 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 STERLINK™ sterilizer.
The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type:
» Sterilization roll, Flat
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/K212198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212198: Tyvek (R) Roll with CI for STERLINKTM Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212198
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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