510(k) · Cleared
ClearedGemini 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 Nov 20, 2015 as substantially equivalent to K112805 (Kimberly-Clark Corp., 2012) after a 247-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it.
- Decided
- Nov 20, 2015
- Review
- 247 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K881471 (1988). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 3 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 2 generations backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 1 generation backK112805 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012
- This deviceK150698 Gemini Sterilization WrapMedline Industries, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK162993 Gemini Sterilization WrapMedline Industries, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K162993Gemini Sterilization WrapMedline Industries, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −3 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −2 | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC… | Kimberly-Clark Corp. | 2009 | — |
| −1 | K112805 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2012 | — |
| 0 (this device) | K150698 | Gemini Sterilization Wrap | Medline Industries, Inc. | 2015 | — |
| +1 | K162993 | Gemini Sterilization Wrap | Medline Industries, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K112805 | Kimguard One-Step Sterilization WrapSummary page 6…Classification Name: Sterilization Wrap Product Code: FRG Classification Panel: General Hospital Predicate Device KIMGUARD ONE-STEP Sterilization Wrap PREDICATE DEVICE K112805 Device Description Gemini Sterilization Wraps are offered to the market place as bulk packages of single and two ply bonded shee… | 2012 |
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 |
|---|---|---|---|
| K162993 | Gemini Sterilization Wrap | 2017 | 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 27 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K162993 (Medline Industries, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K112805.
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?
The Gemini Single Ply and Bonded Sterilization Wraps are intended to allow sterilization of the enclosed medical devices(s) and also maintain sterility of the enclosed medical device(s) within the period of time for which performance data demonstrating maintenance of sterility has been provided. The Gemini Single Ply and Bonded Sterilization Wraps have been validated for use with Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco®…
Read the full statement (107 words)
The Gemini Single Ply and Bonded Sterilization Wraps are intended to allow sterilization of the enclosed medical devices(s) and also maintain sterility of the enclosed medical device(s) within the period of time for which performance data demonstrating maintenance of sterility has been provided.
The Gemini Single Ply and Bonded Sterilization Wraps have been validated for use with Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization Systems.
Table 1 provides a listing of validated sterilization cycles
Table 2 provides recommended weights for each wrap model
Table 3 provides maintenance of package sterility recommendations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150698 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150698: Gemini Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150698
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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