510(k) · Cleared
ClearedSterilization Pouch with Indicators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Winner Industries (Shenzhen) Co., Ltd. · FRG Wrap, Sterilization
Cleared on Jun 8, 2007 as substantially equivalent to K051242 (Winner Medical (Usa), Inc., 2005) and 2 other predicates after a 270-day review. Its family tree reaches back 3 generations to 1999. 7 later devices descend from it.
- Decided
- Jun 8, 2007
- Review
- 270 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K990567 (1999). 7 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
- 2 generations backK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
- 1 generation backK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
- This deviceK062704 Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd. · 2007
- Descendant · cites it directly · 6 of its ownK112591 Safe Secure Sterilization Pounch with Steam and Ethylene Oxide…Safe Secure Packaging Co., Ltd. · 2012
- Descendant · 2 generations on · 4 of its ownK153540 Safe Secure Sterilization Pouch with Steam and Ethylene Oxide…Safe Secure Packaging Co., Ltd. · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK180139 Safe Secure Sterilization Pouches and RollsSafe Secure Packing Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK250306 Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK243431 Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K112591Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. · 2012 · cites it directly6descendants
- K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. · 2016 · 2 generations on4descendants
- K180139Safe Secure Sterilization Pouches and RollsSafe Secure Packing Co., Ltd. · 2019 · 3 generations on1descendant
- K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc. · 2025 · 3 generations on0descendants
- K243431Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990567 | Global Healthcare Self-Sealing Sterilization Pouch | Global Healthcare, Inc. | 1999 | — |
| −2 | K993764 | Medipack See-Through Seal Sterilization Pouch | Medipack Medical Packaging Mfg. Co. | 1999 | — |
| −1 | K051242 | Winner Self Seal Sterilization Pouch | Winner Medical (Usa), Inc. | 2005 | — |
| 0 (this device) | K062704 | Sterilization Pouch with Indicators | Winner Industries (Shenzhen) Co., Ltd. | 2007 | — |
| +1 | K112591 | Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process… | Safe Secure Packaging Co., Ltd. | 2012 | — |
| +2 | K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators | Safe Secure Packaging Co., Ltd. | 2016 | 43 |
| +3 | K180139 | Safe Secure Sterilization Pouches and Rolls | Safe Secure Packing Co., Ltd. | 2019 | — |
| +3 | K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | 2025 | — |
| +3 | K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K051242 | Winner Self Seal Sterilization PouchSummary page 1…th indicators 3. Classification Name: Pack, Sterilization Wrapper, Bag and Accessories (21 CFR 880.6850). 4. Predicate Device: a. K051242 - Winner® Self Seal Sterilization Pouch. b. K993764 - Medipack® See-Through Self Seal Sterilization Pouch.… | 2005 |
| * | K993764 | Medipack See-Through Seal Sterilization PouchSummary page 1…Wrapper, Bag and Accessories (21 CFR 880.6850). 4. Predicate Device: a. K051242 - Winner® Self Seal Sterilization Pouch. b. K993764 - Medipack® See-Through Self Seal Sterilization Pouch. c. K990567 - Global Healthcare Self-Sealing Sterilization Po… | 1999 |
| * | K990567 | Global Healthcare Self-Sealing Sterilization PouchSummary page 1…vice: a. K051242 - Winner® Self Seal Sterilization Pouch. b. K993764 - Medipack® See-Through Self Seal Sterilization Pouch. c. K990567 - Global Healthcare Self-Sealing Sterilization Pouch. Page 1 of 2… | 1999 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112591 | Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process Indicators | 2012 | 6 |
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 8 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112591 (Safe Secure Packaging Co., Ltd., 2012) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K051242.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or greater than or equal to 600 mg/I of ethylene oxide (EtO) for 1 hour at 550 C and 70%RH. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The process indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062704 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062704: Sterilization Pouch with Indicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062704
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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