510(k) · Cleared
ClearedU&U Sterilization Pouch and 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 Sep 9, 2015 as substantially equivalent to K102158 (Sigma Medical Supplies Corp., 2011) after a 261-day review. Its family tree reaches back 5 generations to 1999. 4 later devices descend from it.
- Decided
- Sep 9, 2015
- Review
- 261 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K990567 (1999). 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
- 4 generations backK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
- 3 generations backK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
- 2 generations backK070428 Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007
- 1 generation backK102158 Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011
- This deviceK143637 U&U Sterilization Pouch and RollU&U Medical Technology Co, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK162258 Self Sealing Sterilization PouchesTianchang Jiarui Packaging Material Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK182184 Paper Sterilization Pouch and Roll (Sterilization Pouch Flat…Mdk (Shanghai) Medical Packing Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK183356 Disposable Medical Device Self-seal Sterilization Pouch, Disposable…Weihai Xingtai Packaging Products Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK181957 Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization…Tianchang Jiarui Packaging Material Co., Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K162258Self Sealing Sterilization PouchesTianchang Jiarui Packaging Material Co., Ltd. · 2017 · cites it directly1descendant
- K182184Paper Sterilization Pouch and Roll (Sterilization Pouch Flat, Sterilization Pouch…Mdk (Shanghai) Medical Packing Co., Ltd. · 2019 · cites it directly0descendants
- K183356Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device…Weihai Xingtai Packaging Products Co., Ltd. · 2019 · 2 generations on0descendants
- K181957Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat…Tianchang Jiarui Packaging Material Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990567 | Global Healthcare Self-Sealing Sterilization Pouch | Global Healthcare, Inc. | 1999 | — |
| −4 | K993764 | Medipack See-Through Seal Sterilization Pouch | Medipack Medical Packaging Mfg. Co. | 1999 | — |
| −3 | K051242 | Winner Self Seal Sterilization Pouch | Winner Medical (Usa), Inc. | 2005 | — |
| −2 | K070428 | Medicom Self-Sealing Sterilization Pouch | A.R. Medicom, Inc. | 2007 | — |
| −1 | K102158 | Sigma Sterilization Pouch & Roll | Sigma Medical Supplies Corp. | 2011 | — |
| 0 (this device) | K143637 | U&U Sterilization Pouch and Roll | U&U Medical Technology Co, Ltd. | 2015 | — |
| +1 | K162258 | Self Sealing Sterilization Pouches | Tianchang Jiarui Packaging Material Co., Ltd. | 2017 | — |
| +1 | K182184 | Paper Sterilization Pouch and Roll (Sterilization Pouch Flat, Sterilization… | Mdk (Shanghai) Medical Packing Co., Ltd. | 2019 | — |
| +2 | K183356 | Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical… | Weihai Xingtai Packaging Products Co., Ltd. | 2019 | — |
| +1 | K181957 | Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch… | Tianchang Jiarui Packaging Material Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 3 | 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 |
|---|---|---|---|
| * | K102158 | Sigma Sterilization Pouch & RollSummary page 6…neral Hospital Product code: 1) FRG 2) JOJ 3. Predicate Devices Information: Trade Name: SIGMA Sterilization Pouch and Roll 510(K) Number: K102158 Manufacturer: SIGMA Medical Supplies Corp. 4. Devices Description: The U&U Sterilization Pouch and Roll are m… | 2011 |
What descends from it? (4)
3 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?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K162258 (Tianchang Jiarui Packaging Material Co., Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K102158.
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 U&U sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam and Ethylene Oxide (EtO). The recommended gravity steam sterilization cycle parameters are 30 minutes at 121° C. The recommended EtO sterilization cycle is 4 hours at 55° C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and…
Read the full statement (202 words)
The U&U sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam and Ethylene Oxide (EtO). The recommended gravity steam sterilization cycle parameters are 30 minutes at 121° C. The recommended EtO sterilization cycle is 4 hours at 55° C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 90 Days post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
STERILIZATION CYCLE:
The recommended gravity steam sterilization cycle parameters
Steam sterilization temperature: 121°C (250 °F)
Steam sterilization time: 30 minutes.
Drying time: 25 minutes
The recommended EtO sterilization cycle parameters
EtO sterilization temperature: 55°C (130 °F)
EtO sterilization time: 4 hour
EtO sterilization humidity: 50% to 85% RH
EtO sterilization concentration: 600mg/L
Aeration time: 8 hours.
Aeration Temperature: 60°C
Sterilization load claim:
Two types of sterilization loads were validated.
Load A: Metal medical instruments and Hand-control pen, the total weight is 24lbs.
Load B: Tubing (Silicone) and Surgical Towels. The total weight is 18lbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143637: U&U Sterilization Pouch and Roll.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143637
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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