510(k) · Cleared
ClearedSterilization Pouch/Roll
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterivic Medical Co., Ltd. · FRG Wrap, Sterilization
Cleared on Jan 28, 2026 as substantially equivalent to K221875 (Qianjiang Kingphar Medical Packaging & Printing Co., Ltd., 2023) after a 273-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Jan 28, 2026
- Review
- 273 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K990567 (1999). No later device cites it as a predicate yet.
- Root · 7 generations backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
- 6 generations backK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
- 5 generations backK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
- 4 generations backK070428 Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007
- 3 generations backK102158 Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011
- 2 generations backK212338 SterileRight sterilization pouch and rollSterileright Packaging Mfg., Inc. · 2021
- 1 generation backK221875 Sterilization Pouch and RollQianjiang Kingphar Medical Packaging & Printing Co., Ltd. · 2023
- This deviceK251347 Sterilization Pouch/RollSterivic Medical Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K990567 | Global Healthcare Self-Sealing Sterilization Pouch | Global Healthcare, Inc. | 1999 | — |
| −6 | K993764 | Medipack See-Through Seal Sterilization Pouch | Medipack Medical Packaging Mfg. Co. | 1999 | — |
| −5 | K051242 | Winner Self Seal Sterilization Pouch | Winner Medical (Usa), Inc. | 2005 | — |
| −4 | K070428 | Medicom Self-Sealing Sterilization Pouch | A.R. Medicom, Inc. | 2007 | — |
| −3 | K102158 | Sigma Sterilization Pouch & Roll | Sigma Medical Supplies Corp. | 2011 | — |
| −2 | K212338 | SterileRight sterilization pouch and roll | Sterileright Packaging Mfg., Inc. | 2021 | — |
| −1 | K221875 | Sterilization Pouch and Roll | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. | 2023 | — |
| 0 (this device) | K251347 | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K221875 | Sterilization Pouch and RollSummary page 8…el: General Hospital 3. Predicate device Manufacturer: Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. Trade Name: Sterilization pouch and roll 510(k) Number: K221875 Reference device: Manufacturer: Sigma Medical Supplies Corp. Trade Name: SIGMA Sterilization Pouch and Roll 510(k) Number: K1806… | 2023 |
| † | K180661 | SIGMA Sterilization Pouch and Roll | 2018 |
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 27 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K221875.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Sterilization Pouch/Roll is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: • Steam Sterilization at 132° C (270 ° F) for 4 minutes; Drying time of 20 minutes. • Ethylene Oxide (EO) with a concentration of 695 mg/Lat 50° C (122° F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7…
Read the full statement (213 words)
The Sterilization Pouch/Roll is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
• Steam Sterilization at 132° C (270 ° F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 695 mg/Lat 50° C (122° F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature.
The Sterilization Pouch/Roll is made with medical grade paper and medical compound film. The Sterilization Pouch/Roll maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from Pink before sterilization to Yellow after sterilization. The steam sterilization indicator color change from Blue before sterilization to Black after sterilization.
The specification and recommended sterilization load of the device is following: see attached page
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251347: 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/K251347
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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