510(k) · Cleared
ClearedHeat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianchang Jiarui Packaging Material Co., Ltd. · FRG Wrap, Sterilization
Cleared on Jul 9, 2019 as substantially equivalent to K143637 (U&U Medical Technology Co, Ltd., 2015) after a 351-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Jul 9, 2019
- Review
- 351 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K990567 (1999). No later device cites it as a predicate yet.
- Root · 6 generations backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
- 5 generations backK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
- 4 generations backK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
- 3 generations backK070428 Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007
- 2 generations backK102158 Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011
- 1 generation backK143637 U&U Sterilization Pouch and RollU&U Medical Technology Co, Ltd. · 2015
- This deviceK181957 Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization…Tianchang Jiarui Packaging Material Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K990567 | Global Healthcare Self-Sealing Sterilization Pouch | Global Healthcare, Inc. | 1999 | — |
| −5 | K993764 | Medipack See-Through Seal Sterilization Pouch | Medipack Medical Packaging Mfg. Co. | 1999 | — |
| −4 | K051242 | Winner Self Seal Sterilization Pouch | Winner Medical (Usa), Inc. | 2005 | — |
| −3 | K070428 | Medicom Self-Sealing Sterilization Pouch | A.R. Medicom, Inc. | 2007 | — |
| −2 | K102158 | Sigma Sterilization Pouch & Roll | Sigma Medical Supplies Corp. | 2011 | — |
| −1 | K143637 | U&U Sterilization Pouch and Roll | U&U Medical Technology Co, Ltd. | 2015 | — |
| 0 (this device) | K181957 | Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch… | Tianchang Jiarui Packaging Material Co., Ltd. | 2019 | — |
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 |
|---|---|---|---|
| * | K143637 | U&U Sterilization Pouch and RollSummary page 10…is design is convenient to enclose the medical devices with certain height. 5. Identification of Predicate Device(s) Predicate Device 510(k) Number: K143637 Product Name: U & U Sterilization Pouch and Roll Model Name: U&U Medical Technology Co., Ltd.… | 2015 |
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 20 years and passes through 7 companies; a new generation was cleared every 4.0 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K143637.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Heat Sealing Sterilization Pouch Flat are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Heat Sealing Sterilization Pouch Flat are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with…
Read the full statement (922 words)
The Heat Sealing Sterilization Pouch Flat are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
The Heat Sealing Sterilization Pouch Flat are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.
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.
The Heat Sealing Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 600 mm size pouch is 1470 g, 200 x 300 mm size pouch is 300g, 90 x 559 mm size pouch is 250g, and 102 x 203 size pouch is 110g.
The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization.
Heat Sealing Sterilization Pouch Gusseted
The Heat Sealing Sterilization Pouch Gusseted are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
The Heat Sealing Sterilization Pouch Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.
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.
The Heat Sealing Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 300 x 65 x 560 mm size pouch is 1050g, 200 x 33 x 340 mm size pouch is 400g, and 65 x 40 x 254 mm size pouch is 200g.
The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization.
Device Size (mm): 65ⅹ40ⅹ254,70 x 35 x 145,90 x 50 x 155,128 x 50 X 190,137ⅹ40ⅹ305, 150ⅹ50ⅹ380, 165ⅹ75ⅹ295, 200ⅹ33ⅹ340, 200ⅹ98ⅹ440,250ⅹ60ⅹ340,250ⅹ60ⅹ480,300ⅹ65ⅹ560.
Heat Sealing Sterilization Pouch Roll Flat
The Heat Sealing Sterilization Roll Flat are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
The Heat Sealing Sterilization Roll Flat are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.
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.
The Heat Sealing Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 600 x 200 mm size pouch is 910g, 300 x 200 mm size pouch is 450g and 50 x 200 mm size pouch is 100g.
The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization.
Device Size (mm): 50 x 200,75 x 200,100 x 200,120 x 200,150 x 200,200 x 200,250 x 200,300 x 200,350 x 200, 400 x 200, 500 x 200,600 x 200.
Heat Sealing Sterilization Pouch Roll Gusseted
The Heat Sealing Sterilization Roll Gusseted are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
The Heat Sealing Sterilization Roll Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.
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.
The Heat Sealing Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 100 mm size pouch is 750g, 250 x 100 mm size pouch is 375g and 75 x 100 mm size pouch is 100g.
The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization.
Device Size (mm): 75 x 100,100 x 100,150 x 100,200 x 100,250x 100,300 x 100,350 x 100,400 x 100,500 x 100.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181957: Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181957
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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