510(k) · Cleared
ClearedPaper Sterilization Pouch and Roll (Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mdk (Shanghai) Medical Packing Co., Ltd. · FRG Wrap, Sterilization
Cleared on Oct 10, 2019 as substantially equivalent to K143637 (U&U Medical Technology Co, Ltd., 2015) after a 423-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Oct 10, 2019
- Review
- 423 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 deviceK182184 Paper Sterilization Pouch and Roll (Sterilization Pouch Flat…Mdk (Shanghai) Medical Packing 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) | K182184 | Paper Sterilization Pouch and Roll (Sterilization Pouch Flat, Sterilization… | Mdk (Shanghai) Medical Packing 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 6…Page 1 of 16 510(k) Summary 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. 6. Device Description… | 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 4.1 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?
Sterilization Pouch Flat The 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 Sterilization Pouch Flat are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).…
Read the full statement (697 words)
Sterilization Pouch Flat
The 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 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:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃.
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 Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470 g.
The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.
Sterilization Pouch Gusseted
The 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 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:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃.
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 Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470g.
The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.
Sterilization Roll Flat
The 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 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:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃.
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 Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g.
The sterilization roll maintains the enclosed devices up until 6 months post sterilization.
Sterilization Roll Gusseted
The 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 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:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃.
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 Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g.
The sterilization roll maintains the enclosed devices up until 6 months post sterilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182184 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182184: Paper Sterilization Pouch and Roll (Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182184
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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