510(k) · Cleared
ClearedGemini Titan 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 Jan 24, 2020 as substantially equivalent to K152458 (Medline Industries, Inc., 2016) after a 122-day review. Its family tree reaches back 3 generations to 2013.
- Decided
- Jan 24, 2020
- Review
- 122 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K113353 (2013). No later device cites it as a predicate yet.
- Root · 3 generations backK113353 Gemini Sterilzation WrapMedline Industries, Inc. · 2013
- 2 generations backK143147 Gemini Bonded Sterilization WrapMedline Industries, Inc. · 2015
- 1 generation backK152458 Gemini Bonded Sterilization WrapMedline Industries, Inc. · 2016
- This deviceK192641 Gemini Titan Sterilization WrapMedline Industries, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K113353 | Gemini Sterilzation Wrap | Medline Industries, Inc. | 2013 | — |
| −2 | K143147 | Gemini Bonded Sterilization Wrap | Medline Industries, Inc. | 2015 | — |
| −1 | K152458 | Gemini Bonded Sterilization Wrap | Medline Industries, Inc. | 2016 | — |
| 0 (this device) | K192641 | Gemini Titan Sterilization Wrap | Medline Industries, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K152458 | Gemini Bonded Sterilization WrapSummary page 5…ion Product Code: FRG Classification Panel: General Hospital Regulatory Class: Class II Regulation #: 21 CFR 880.6850 Predicate Device Gemini® Bonded Sterilization Wrap K152458 1 of 5 Medline Industries, Inc.… | 2016 |
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 7 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Titan 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 the enclosed device until used.
-Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for a dry time of 30 minutes. Gemini® Titan™ Sterilization Wrap is available in square sheets ranging from 36” x 36” to 54” x 54” and can be used with trays weighing up to 25 lbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192641: Gemini Titan 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/K192641
Report an extraction error
Are you the manufacturer?
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