510(k) · Cleared
ClearedWrappel T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Standard Textile Co., Inc. · FRG Wrap, Sterilization
Cleared on Apr 8, 1993 after a 272-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Apr 8, 1993
- Review
- 272 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK923408 Wrappel TStandard Textile Co., Inc. · 1993
- Descendant · cites it directly · 2 of its ownK172207 Standard Supreme Sterilization WrapperStandard Textile Co., Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK250321 GCI Sterilization WrappersGeorge Courey, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK234132 Medline Reusable Sterilization WrappersMedline Industries, LP · 2024
- Descendant · cites it directly · 0 of its ownK162162 Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K172207Standard Supreme Sterilization WrapperStandard Textile Co., Inc. · 2017 · cites it directly2descendants
- K250321GCI Sterilization WrappersGeorge Courey, Inc. · 2025 · 2 generations on0descendants
- K234132Medline Reusable Sterilization WrappersMedline Industries, LP · 2024 · 2 generations on0descendants
- K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923408 | Wrappel T | Standard Textile Co., Inc. | 1993 | — |
| +1 | K172207 | Standard Supreme Sterilization Wrapper | Standard Textile Co., Inc. | 2017 | — |
| +2 | K250321 | GCI Sterilization Wrappers | George Courey, Inc. | 2025 | — |
| +2 | K234132 | Medline Reusable Sterilization Wrappers | Medline Industries, LP | 2024 | — |
| +1 | K162162 | Barrier Supreme Sterilization Wrapper | Standard Textile Co., Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 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?
- Of its descendants, K172207 (Standard Textile Co., Inc., 2017) has gone furthest, with 2 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.
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 | — |
https://510kreport.com/device/K923408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923408: Wrappel T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923408
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026