510(k) · Cleared
ClearedGemini Sterilzation Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · FRG Wrap, Sterilization
Cleared on Jan 31, 2013 after a 444-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jan 31, 2013
- Review
- 444 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK113353 Gemini Sterilzation WrapMedline Industries, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK143147 Gemini Bonded Sterilization WrapMedline Industries, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK152458 Gemini Bonded Sterilization WrapMedline Industries, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK192641 Gemini Titan Sterilization WrapMedline Industries, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK152564 Gemini Sterilization WrapMedline Industries, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K143147Gemini Bonded Sterilization WrapMedline Industries, Inc. · 2015 · cites it directly2descendants
- K152458Gemini Bonded Sterilization WrapMedline Industries, Inc. · 2016 · 2 generations on1descendant
- K192641Gemini Titan Sterilization WrapMedline Industries, Inc. · 2020 · 3 generations on0descendants
- K152564Gemini Sterilization WrapMedline Industries, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K113353 | Gemini Sterilzation Wrap | Medline Industries, Inc. | 2013 | — |
| +1 | K143147 | Gemini Bonded Sterilization Wrap | Medline Industries, Inc. | 2015 | — |
| +2 | K152458 | Gemini Bonded Sterilization Wrap | Medline Industries, Inc. | 2016 | — |
| +3 | K192641 | Gemini Titan Sterilization Wrap | Medline Industries, Inc. | 2020 | — |
| +1 | K152564 | Gemini Sterilization Wrap | Medline Industries, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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, K143147 (Medline Industries, Inc., 2015) has gone furthest, with 2 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. 2013, 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?
Gemini Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of such content for 180 days following sterilization. Gemini Sterilization Wrap is validated for use in steam or STERRAD' sterilization processes in the following sterilization modes and cycles. * Pre-vacuum steam cycles o…
Read the full statement (136 words)
Gemini Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of such content for 180 days following sterilization. Gemini Sterilization Wrap is validated for use in steam or STERRAD' sterilization processes in the following sterilization modes and cycles.
* Pre-vacuum steam cycles
o 4 Minutes Exposure at 270 0F/1320 C with minimum 20 minutes dry time
* Gravity steam cycles
o 30 Minutes Exposure at 2500 F/1210 C with minimum 20 minutes dry time
* STERRADO Sterilization
o STERRADO IOONX, Flex cycle
o STERRADt IOONX, Standard cycle
o STERRADO 100ONX, Express cycle
o STERRADO 100S, Standard cycle
o STERRAD t NX, Advanced cycle
o STERRAD®NX, Standard cycle
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K113353 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113353: Gemini Sterilzation Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113353
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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