510(k) · Cleared
ClearedSelf Sealing Sterilization Pouches
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 Apr 28, 2017 as substantially equivalent to K143637 (U&U Medical Technology Co, Ltd., 2015) after a 260-day review. Its family tree reaches back 6 generations to 1999. 1 later device descends from it.
- Decided
- Apr 28, 2017
- Review
- 260 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K990567 (1999). 1 later device descends from it, 1 citing it directly.
- 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 deviceK162258 Self Sealing Sterilization PouchesTianchang Jiarui Packaging Material Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK183356 Disposable Medical Device Self-seal Sterilization Pouch, Disposable…Weihai Xingtai Packaging Products Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K183356Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device…Weihai Xingtai Packaging Products Co., Ltd. · 2019 · cites it directly0descendants
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) | K162258 | Self Sealing Sterilization Pouches | Tianchang Jiarui Packaging Material Co., Ltd. | 2017 | — |
| +1 | K183356 | Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical… | Weihai Xingtai Packaging Products Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K143637 | U&U Sterilization Pouch and RollSummary page 6…ene oxide gas. The validated maintenance of sterility period is 6 months. 5. Identification of Predicate Device(s) Predicate Device 510(k) Number: K143637 Product Name: Winner Self Seal Sterilization Pouch Model Name: U&U Medical Technology Co., Ltd. The comparison t… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183356 | Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device… | 2019 | 0 |
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 18 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.
- Of its descendants, K183356 (Weihai Xingtai Packaging Products Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 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. 2017, 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 Self Sealing Sterilization Pouches 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 Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The…
Read the full statement (260 words)
The Self Sealing Sterilization Pouches 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 Self Sealing Sterilization Pouches 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 Self Sealing sterilization Pouches are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 540g or 1.19 lbs. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.
The pouches are available in the following sizes:
Model(s): 57 x 102mm, 57 x 130 mm, 70 x 255 mm, 83 x 165 mm, 90 x 260 mm, 133 x 191 mm, 133 x 279 mm, 133 x 290 mm, 140 x 280 mm, 140 x 330 mm, 180 x 330 mm, 190 x 330 mm, 190 x 360 mm, 255 x 380 mm, 279 x 406 mm, 300 x 400 mm, 300 x 474 mm, 305 x 457 mm;
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162258: Self Sealing Sterilization Pouches.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162258
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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