510(k) · Cleared
ClearedDukal SMS 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 Mar 22, 2024 as substantially equivalent to K082554 (Kimberly-Clark Corp., 2009) and 1 other predicate after a 175-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Mar 22, 2024
- Review
- 175 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K881471 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 2 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 1 generation backK143053 KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care · 2015
- This deviceK233262 Dukal SMS Sterilization WrapDukal, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −2 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −1 | K143053 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | 2015 | — |
| 0 (this device) | K233262 | Dukal SMS Sterilization Wrap | Dukal, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (2)
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 |
|---|---|---|---|
| * | K082554 | Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600Summary page 7…oduct Code: FRG 12. Predicate Device: o Kimguard Sterilization wrap, models KC100, KC200, KC300, KC400, KC500 and KC600 K082554 Cleared: 05/01/2009 o Kimguard One-Step Sterilization Wrap K143053 Clea… | 2009 |
| * | K143053 | KIMGUARD ONE-STEP Sterilization WrapSummary page 7…KC100, KC200, KC300, KC400, KC500 and KC600 K082554 Cleared: 05/01/2009 o Kimguard One-Step Sterilization Wrap K143053 Cleared: 04/03/2015 1 of 12 13. Device Des… | 2015 |
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 36 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 3 other devices also cite its predicate K082554.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 SMS sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: * In a steam sterilization pre-vacuum cycle at 270°F / 132°C for 4 minutes 0 Models 100, 200 and 300 were validated for dry times of 20 minutes; models 400, 500 and 600 were validated for dry times of 30 minutes. * In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80%…
Read the full statement (196 words)
The Dukal SMS sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:
* In a steam sterilization pre-vacuum cycle at 270°F / 132°C for 4 minutes
0 Models 100, 200 and 300 were validated for dry times of 20 minutes; models 400, 500 and 600 were validated for dry times of 30 minutes.
* In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes.
o The wrap was validated for aeration times for EO sterilization of 16 hours at 40.0°C.
Dukal SMS sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) for 6 months or until opened. The devices are intended for over-the-counter use and are single use disposable sterilization wraps.
Test results validated that the Dukal SMS sterilization wraps allowed sterilization of the enclosed medical device(s) by ethylene oxide sterilization and by pre-vacuum cycles.
These models of the Dukal SMS sterilization wrap have been validated for use with the ethylene oxide and pre-vacuum cycles listed in below table:
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233262: Dukal SMS Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233262
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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