# K250306: Chex-All Sterilization Pouches and Tubes

- Pathway: 510(k) (Abbreviated)
- Applicant: Propper Manufacturing Co., Inc.
- Decided: Oct 31, 2025 after 270 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 7.

## Indications for use
Chex-All® Sterilization Pouches and Tubes are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using: Hospital size sterilizer cycles • Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time • Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time • Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time Tabletop sterilizer cycles: • Pre-vacuum steam at 132°C (270°F) for 4 minutes; 30 minutes dry time Ethylene Oxide sterilization cycles: • Ethylene Oxide (EO) with a concentration of 736 mg/L at 55°C (131°F) and 50% to 60% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F). Chex-All sterilization pouches and tubes can be used for steam sterilization of devices with lumens at maximum load as the following: Metal lumen: 7 inch long, 3.2mm internal diameter Plastic lumen: 5 inch long, 2.0 mm internal diameter. Suitable Lumen cycles: Hospital size sterilizers: pre-vacuum cycles with 132°C-4.0 min exposure (20 minutes dry time) and 135°C-3.0 min exposure (16 minutes dry time). Table-top sterilizers: pre-vacuum cycle with 132°C-4.0 min exposure (30 minutes dry time). Chex-All sterilization pouches and tubes can be used for steam sterilization in double pouch configuration, in gravity 250°F-30 min exposure cycles (25 minutes dry time) and in pre-vacuum 270°F-4 min exposure cycles (20 minutes dry time). The Process chemical indicators on the Chex-All sterilization pouches and tubes are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed pouches. The chemical indicators change from crème to gray/black after exposure to steam and from beige-pink to green after exposure to ethylene oxide. If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and to maintain sterility (SAL≥10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 30 months after steam sterilization and 12 months after EO sterilization. The maximum pouch load is 2.65 lb. (1.2 kg) or less. The maximum pouch load for table-top sterilizers is 1.10 lb. (0.5 kg) or less. The maximum pouch size for use in table-top sterilizers is 13”x18”.

Source page: https://510kreport.com/device/K250306
Methodology: https://510kreport.com/methodology