510(k) · Cleared
ClearedSterilization Wrap-Sterisheet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arjo Wiggins Medical, Inc. · FRG Wrap, Sterilization
Cleared on Dec 16, 1993 after a 282-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 16, 1993
- Review
- 282 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK931202 Sterilization Wrap-SterisheetArjo Wiggins Medical, Inc. · 1993
- Descendant · cites it directly · 3 of its ownK152291 Sterisheet Sterilization WrapAndersen Sterilizers, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK200335 Sterisheet Sterilization WrapAndersen Sterilizers, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK252823 Dukal Crepe Paper Sterilization WrapDukal, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK170437 Sterisheet Sterilization WrapAndersen Sterilizers, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK062100 Arjowrap 47/100 and 47/88Arjo Wiggins Medical, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K152291Sterisheet Sterilization WrapAndersen Sterilizers, Inc. · 2015 · cites it directly3descendants
- K200335Sterisheet Sterilization WrapAndersen Sterilizers, Inc. · 2020 · 2 generations on1descendant
- K252823Dukal Crepe Paper Sterilization WrapDukal, LLC · 2026 · 3 generations on0descendants
- K170437Sterisheet Sterilization WrapAndersen Sterilizers, Inc. · 2017 · 2 generations on0descendants
- K062100Arjowrap 47/100 and 47/88Arjo Wiggins Medical, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931202 | Sterilization Wrap-Sterisheet | Arjo Wiggins Medical, Inc. | 1993 | — |
| +1 | K152291 | Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. | 2015 | — |
| +2 | K200335 | Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. | 2020 | — |
| +3 | K252823 | Dukal Crepe Paper Sterilization Wrap | Dukal, LLC | 2026 | — |
| +2 | K170437 | Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. | 2017 | — |
| +1 | K062100 | Arjowrap 47/100 and 47/88 | Arjo Wiggins Medical, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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, K152291 (Andersen Sterilizers, Inc., 2015) has gone furthest, with 3 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/K931202 · printed Nov 4, 2026
Cite this page
510(k) Report. “K931202: Sterilization Wrap-Sterisheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K931202
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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