510(k) · Cleared
ClearedKimguard Smart-Fold* Sterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · FRG Wrap, Sterilization
Cleared on Jan 19, 2012 as substantially equivalent to K082177 (Kimberly-Clark Corp., 2009) after a 162-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Jan 19, 2012
- Review
- 162 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881471 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 1 generation backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- This deviceK112300 Kimguard Smart-Fold* Sterilization WrapKimberly-Clark Corp. · 2012
- Descendant · cites it directly · 0 of its ownK140963 Kimguard Smart-Fold Sterilization WrapKimberly-Clark Corp. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140963Kimguard Smart-Fold Sterilization WrapKimberly-Clark Corp. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −1 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| 0 (this device) | K112300 | Kimguard Smart-Fold* Sterilization Wrap | Kimberly-Clark Corp. | 2012 | — |
| +1 | K140963 | Kimguard Smart-Fold Sterilization Wrap | Kimberly-Clark Corp. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K082177 | Kimguard One-Step Sterilization WrapSummary page 3…0250, KC450, KC5SO, and K0650) is substantially equivalent to the predicate KimGuard One-Step t Sterilization Wrap (Models KCiQO, K0200, K0300, KC400, KCSOO, and KC600) (K0821 77). Substantial Equivalence: The modified design of KimGuard Smart-Fold t Sterilization Wrap is substantially equivalent to the pr… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140963 | Kimguard Smart-Fold Sterilization Wrap | 2014 | 0 |
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 24 years and passes through 1 company; a new generation was cleared every 20.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K140963 (Kimberly-Clark Corp., 2014) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K082177.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
KimGuard Smart-Fold* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 2700 F/1 32CC for 4 minutes or by 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131 OF/ 550C and 40% - 80% relative humidity for 60 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed…
Read the full statement (147 words)
KimGuard Smart-Fold* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 2700 F/1 32CC for 4 minutes or by 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131 OF/ 550C and 40% - 80% relative humidity for 60 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EQ sterilization of 8 hours at 131OF/155 0C or 12 hours at 110 0'F/ 43.30 C. The KimGuard Smart-Fold t Sterilization Wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Model K0250 and for dry times of 30 minutes for Models KC450, KC550 and KC650.
See Wrap Model Recommendations on Page 2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112300: Kimguard Smart-Fold* 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/K112300
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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