510(k) · Cleared
ClearedDisposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weihai Xingtai Packaging Products Co., Ltd. · FRG Wrap, Sterilization
Cleared on Aug 19, 2019 as substantially equivalent to K162258 (Tianchang Jiarui Packaging Material Co., Ltd., 2017) after a 258-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Aug 19, 2019
- Review
- 258 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 backK143637 U&U Sterilization Pouch and RollU&U Medical Technology Co, Ltd. · 2015
- 1 generation backK162258 Self Sealing Sterilization PouchesTianchang Jiarui Packaging Material Co., Ltd. · 2017
- This deviceK183356 Disposable Medical Device Self-seal Sterilization Pouch, Disposable…Weihai Xingtai Packaging Products Co., Ltd. · 2019
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 | 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 | — |
| 0 (this device) | K183356 | Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical… | Weihai Xingtai Packaging Products 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 |
|---|---|---|---|
| * | K162258 | Self Sealing Sterilization PouchesSummary page 5…n: 2 Product Code: FRG/JOJ Regulation Number: 21 CFR 880.6850/ 21 CFR 880.2800 Review Panel: General Hospital Predicate devices: 510(k) Number: K162258 Device Name: Self Sealing Sterilization Pouches (primary predicate) 510(k) Number: K102158 Device Name: SIGMA Sterilization… | 2017 |
| † | K102158 | Sigma Sterilization Pouch & Roll | 2011 |
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 8 companies; a new generation was cleared every 2.3 years on median.
- None of the 7 ancestors has a recall.
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?
Disposable Medical Device Self-seal Sterilization Pouch The Disposable Medical Device Self-seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves. The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch…
Read the full statement (210 words)
Disposable Medical Device Self-seal Sterilization Pouch
The Disposable Medical Device Self-seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves.
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process.
The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments.
Disposable Medical Device Sterilization Reel Pouch
The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves.
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process.
The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183356 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183356: Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183356
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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