510(k) · Cleared
ClearedTidi Brand Sterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Banta Healthcare Group, Ltd. · FRG Wrap, Sterilization
Cleared on Nov 17, 2004 as substantially equivalent to K800123 (Ahlstrom Dexter, 1980) after a 56-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Nov 17, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K800123 (1980). No later device cites it as a predicate yet.
- Root · 1 generation backK800123 Dextex II Sterilization WrapAhlstrom Dexter · 1980
- This deviceK042580 Tidi Brand Sterilization WrapBanta Healthcare Group, Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K800123 | Dextex II Sterilization Wrap | Ahlstrom Dexter | 1980 | — |
| 0 (this device) | K042580 | Tidi Brand Sterilization Wrap | Banta Healthcare Group, Ltd. | 2004 | — |
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 |
|---|---|---|---|
| * | K800123 | Dextex II Sterilization WrapSummary page 2…d instruments. Predicate Devices: The predicate device referenced in this submission is: AhIstrom Dexter - Dextex II Sterilization Wrap, 510(k) # K800123 Safety and Effectiveness: The differences between the Banta Healthcare Group Tidi Brand Sterilization/CSR Wrap specifications… | 1980 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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 | — |
What is it indicated for?
Tidi brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment.
Available in numerous sizes, CSR wrap is a single-use product intended for use in steam and ethylene oxide sterilization applications. The wraps maintain their wrapped integrity after sterilization to maintain contents' sterility before use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042580 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042580: Tidi Brand Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042580
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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