510(k) · Cleared
ClearedDukal Crepe Paper Sterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dukal, LLC · FRG Wrap, Sterilization
Cleared on May 28, 2026 as substantially equivalent to K200335 (Andersen Sterilizers, Inc., 2020) after a 266-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- May 28, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931202 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK931202 Sterilization Wrap-SterisheetArjo Wiggins Medical, Inc. · 1993
- 2 generations backK152291 Sterisheet Sterilization WrapAndersen Sterilizers, Inc. · 2015
- 1 generation backK200335 Sterisheet Sterilization WrapAndersen Sterilizers, Inc. · 2020
- This deviceK252823 Dukal Crepe Paper Sterilization WrapDukal, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931202 | Sterilization Wrap-Sterisheet | Arjo Wiggins Medical, Inc. | 1993 | — |
| −2 | K152291 | Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. | 2015 | — |
| −1 | K200335 | Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. | 2020 | — |
| 0 (this device) | K252823 | Dukal Crepe Paper Sterilization Wrap | Dukal, LLC | 2026 | — |
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 |
|---|---|---|---|
| * | K200335 | Sterisheet Sterilization WrapSummary page 6…Sterilization Wrap 11. Product Code: FRG 12. Predicate Device: a. Sterisheet Sterilization Wrap i. K200335 ii. Cleared: 11/12/2020 13. Reference Device: a. Dukal SMS Sterilization Wrap i. K233262… | 2020 |
| † | K233262 | Dukal SMS Sterilization Wrap | 2024 |
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?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Dukal Crepe Paper sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:
• In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131˚F / 55˚C and 40-80% relative humidity for 120 minutes.
o The wrap was validated for aeration times for EO sterilization of 24 hours at 40.0˚C.
Dukal Crepe Paper sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) until opened. The devices are intended for over-the-counter use and are single use disposable sterilization wraps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252823 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252823: Dukal Crepe Paper Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252823
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026