# K243431: Medicom Sterilization Pouch and Reel

- Pathway: 510(k) (Traditional)
- Applicant: Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.
- Decided: Feb 21, 2025 after 108 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K990567 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153540: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators, Safe Secure Packaging Co., Ltd. (2016) Summary page 11.

## Indications for use
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.):

Source page: https://510kreport.com/device/K243431
Methodology: https://510kreport.com/methodology