510(k) · Cleared
ClearedMedicom Sterilization Pouch and Reel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. · FRG Wrap, Sterilization
Cleared on Feb 21, 2025 as substantially equivalent to K153540 (Safe Secure Packaging Co., Ltd., 2016) after a 108-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Feb 21, 2025
- Review
- 108 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 backK062704 Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd. · 2007
- 2 generations backK112591 Safe Secure Sterilization Pounch with Steam and Ethylene Oxide…Safe Secure Packaging Co., Ltd. · 2012
- 1 generation backK153540 Safe Secure Sterilization Pouch with Steam and Ethylene Oxide…Safe Secure Packaging Co., Ltd. · 2016 · Recalled
- This deviceK243431 Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch. · 2025
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 | K062704 | Sterilization Pouch with Indicators | Winner Industries (Shenzhen) Co., Ltd. | 2007 | — |
| −2 | K112591 | Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process… | Safe Secure Packaging Co., Ltd. | 2012 | — |
| −1 | K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators | Safe Secure Packaging Co., Ltd. | 2016 | 43 |
| 0 (this device) | K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 2025 | — |
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 |
|---|---|---|---|
| * | K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSummary page 11…ation Number: 1) 21 CFR 880.6850 2) 21 CFR 880.2800 Predicate Devices The predicate device [510(k) Notification K153540, cleared August 4, 2016] is the Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators.… | 2016 |
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 26 years and passes through 6 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 2 other devices also cite its predicate K153540.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Medicom Sterilization Pouch and Reel are intended to provide health care workers with an effective method to enclose devices, and they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes. Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.…
Read the full statement (268 words)
The Medicom Sterilization Pouch and Reel are intended to provide health care workers with an effective method to
enclose devices, and they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
Pre-vacuum steam at 134°C (273°F) for 4 minutes; Drying time of 20 minutes.
Ethylene Oxide (EO) with a concentration of 600 mg/L at 50°C (122°F) and 60% to 85% relative humidity for
120 minutes. Single Pouch: Aeration time of 5 days at 25°C (77°F). Double Pouches: Aeration time of 3 days at
25°C (77°F).
Furthermore, there are 3 thicknesses for health care workers to choose from as follows:
Pouch of Combination A: Medical grade paper 60g+laminated film 44pm
Pouch of Combination B: Medical grade paper 60g+laminated film 52pum
Pouch of Combination C: Medical grade paper 70g-+laminated film 52um
The Medicom Sterilization Pouch and Reel which are made with Paper maintains the sterility of the enclosed devices for
up to 1 year 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.
The following table (Table 5-1 to Table 5-3) lists the model numbers of the Medicom Sterilization
Pouch and Reel by type, model, dimensions, and max. load (Ibs.):
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243431: Medicom Sterilization Pouch and Reel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243431
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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