510(k) · Cleared
ClearedStandard Supreme Sterilization Wrapper
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 Aug 25, 2017 as substantially equivalent to K923408 (Standard Textile Co., Inc., 1993) after a 35-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Aug 25, 2017
- Review
- 35 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923408 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923408 Wrappel TStandard Textile Co., Inc. · 1993
- This deviceK172207 Standard Supreme Sterilization WrapperStandard Textile Co., Inc. · 2017
- Descendant · cites it directly · 0 of its ownK250321 GCI Sterilization WrappersGeorge Courey, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK234132 Medline Reusable Sterilization WrappersMedline Industries, LP · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923408 | Wrappel T | Standard Textile Co., Inc. | 1993 | — |
| 0 (this device) | K172207 | Standard Supreme Sterilization Wrapper | Standard Textile Co., Inc. | 2017 | — |
| +1 | K250321 | GCI Sterilization Wrappers | George Courey, Inc. | 2025 | — |
| +1 | K234132 | Medline Reusable Sterilization Wrappers | Medline Industries, LP | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K923408 | Wrappel TSummary page 6…2207 Substantial Equivalence Comparison Standard Supreme Sterilization Wrappers have been shown to be substantially equivalent to WrapPel “T” sterilization wraps K923408. All fabrics used are woven, dyed and treated with a fluoropolymer finish. Fabrics are spread, cut and sewn into the similar i… | 1993 |
What descends from it? (2)
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?
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Standard Supreme Sterilization Wrappers are intended to be used to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. Standard Supreme Sterilization Wrappers will function as a sterilization wrap when processed according to instructions. Standard Supreme Sterilization Wrappers are…
Read the full statement (212 words)
Standard Supreme Sterilization Wrappers are intended to be used to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Standard Supreme Sterilization Wrappers will function as a sterilization wrap when processed according to instructions. Standard Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile sterilization wraps that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Pack Assembly:
Pack assembly should follow established folding, assembly and wrapping procedures as defined by the clinical staff for aseptic presentation of the pack and its contents. The oblong and envelope folds have been validated for use on textile packs. Closure can include autoclave tape and elastomer closures.
Sterilization:
A prevacuum steam sterilization cycle (4 minute exposure at 270oF) has been validated for use on textile packs. The maximum pack size validated for use was 0.58 cubic feet with a pack weight of 12.9 pounds – pack density of 22.4 lbs./cu.ft. The maximum chamber loading configuration included 85.6 pounds of packs in a 9.1 cubic foot chamber – load density of 10.4 lbs./cu.ft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172207: Standard Supreme Sterilization Wrapper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172207
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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