510(k) · Cleared
ClearedU&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/Roll
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&U Medical Technology Co, Ltd. · FRG Wrap, Sterilization
Cleared on Feb 26, 2014 as substantially equivalent to K103210 (Advanced Sterilization Products, 2011) after a 505-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Feb 26, 2014
- Review
- 505 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921910 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 1 generation backK103210 Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad…Advanced Sterilization Products · 2011
- This deviceK123162 U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/RollU&U Medical Technology Co, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −1 | K103210 | Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek… | Advanced Sterilization Products | 2011 | — |
| 0 (this device) | K123162 | U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/Roll | U&U Medical Technology Co, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K103210 | Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with…Summary page 1…Regulation Number: 21CFR 860.6850 3. Predicate Devices Information: Trade Name: Tyvek Pouch/Roll With STERRAD Chemical Indicator 510(K) Number: K103210 Manufacturer: Advanced Sterilization Products Company. 4. Devices Description: The U&U Hydrogen Peroxide Gas Plas… | 2011 |
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 21 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K103210.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roil are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD I100NX Hydrogen Peroxide Gas Plasma sterilizer. The recommended Hydrogen Peroxide Gas Plasma cycle parameter: STERRAD IOGONX STANDARD Cycle Sterilization load claim: STERRAD IOONIX Sterilizer Standard cycle: -General medical instruments (metal and nonmetal, including hinged devices)…
Read the full statement (207 words)
U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roil are intended to be used to
enclose medical devices that are to be terminally sterilized in the STERRAD I100NX Hydrogen
Peroxide Gas Plasma sterilizer.
The recommended Hydrogen Peroxide Gas Plasma cycle parameter:
STERRAD IOGONX STANDARD Cycle
Sterilization load claim:
STERRAD IOONIX Sterilizer Standard cycle:
-General medical instruments (metal and nonmetal, including hinged devices)
-Instruments with single-channel stainless steel lumens with an Internal diameter 3mm or larger
and length 150 mm or shorter.
- Polyethylene and Teflon lumen tubing with an Internal diameter of 3 mm or larger and length of
500 mm or shorter.
* These items must be sterilized without any additional load items
- Limit of 20 pieces of tubing per cycle
Load condition: One device per Sterilization Pouch.
Load chamber Two shelves (total weight: 21.4 lbs or 9.7 kg)
Load Pouch: Leave enough malarial beyond the seal for the opener to easily grasp (usually 1-1
'A Inches).
SHELF UFE: It Is recommended that the products are put to their end use withln 2 years of
manufacture. The recommended "best before data and the manufacturing date are stated on
the label. This device was demonstrated to maintain sterility of the contents for 30 days
after Sterilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123162: U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/Roll.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123162
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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