510(k) · Cleared
ClearedGemini Bonded Sterilization 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 May 7, 2015 as substantially equivalent to K113353 (Medline Industries, Inc., 2013) after a 185-day review. Its family tree reaches back 1 generation to 2013. 2 later devices descend from it.
- Decided
- May 7, 2015
- Review
- 185 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K113353 (2013). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK113353 Gemini Sterilzation WrapMedline Industries, Inc. · 2013
- This deviceK143147 Gemini Bonded Sterilization WrapMedline Industries, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK152458 Gemini Bonded Sterilization WrapMedline Industries, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK192641 Gemini Titan Sterilization WrapMedline Industries, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K113353 | Gemini Sterilzation Wrap | Medline Industries, Inc. | 2013 | — |
| 0 (this device) | K143147 | Gemini Bonded Sterilization Wrap | Medline Industries, Inc. | 2015 | — |
| +1 | K152458 | Gemini Bonded Sterilization Wrap | Medline Industries, Inc. | 2016 | — |
| +2 | K192641 | Gemini Titan Sterilization Wrap | Medline Industries, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K113353 | Gemini Sterilzation WrapSummary page 9…ization Wrap Common Name: Sterilization Wrap Classification Name: Sterilization Wrap (21 CRF 880.6850, product code – FRG) Predicate Device Gemini Sterilization Wrap - K113353 Device Description Gemini Bonded Sterilization Wrap is comprised of two ply sheets ultrasonically bonded together for use by cu… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152458 | Gemini Bonded Sterilization Wrap | 2016 | 1 |
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?
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Bonded 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 Bonded Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles. • Pre-vacuum…
Read the full statement (197 words)
Gemini Bonded 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 Bonded Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles.
• Pre-vacuum steam cycles
* Minimum 4 Minutes Exposure at 270ºF/132ºC with minimum 20 minutes dry time
• Gravity steam cycles
* Maximum 30 Minutes Exposure at 250ºF/121ºC with minimum 20 minutes dry time
• STERRAD® Sterilization
* STERRAD® 100NX, Flex cycle
* STERRAD® 100NX, Standard cycle
* STERRAD® 100NX, Express cycle
* STERRAD® 100S, Standard cycle
* STERRAD® NX, Advanced cycle
* STERRAD® NX, Standard cycle
The Gemini Bonded Sterilization Wrap intended loads with pre-vacuum steam sterilization, gravity steam sterilization, and the Advanced Sterilization Products (ASP) STERRAD® 100NX, STERRAD® 100S, and STERRAD® NX cycles are provided in Table 1.
The Gemini Bonded Sterilization Wrap Recommendations for Use with Pre-vacuum steam cycles, Gravity steam cycles, and the Advanced Sterilization Products STERRAD® Sterilization Systems are provide in Table 2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143147: Gemini Bonded 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/K143147
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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