# K141826: Flashpak Sterilization Container System

- Pathway: 510(k) (Traditional)
- Applicant: Symmetry Medical Inc- Manchester
- Decided: Apr 2, 2015 after 269 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: 2 generations back to K871202 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113776: Flashpak, Symmetry Medical (2012) Summary page 4.

## Indications for use
FlashPak® is a reusable rigid container system to be used during immediate use steam sterilization (IUSS or flash) by hospitals and healthcare facilities. It is intended to enable sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravity-displacement steam sterilization using a 10 minute cycle at 132° C for porous items and items with lumens or a 3 minute cycle at 132° C for nonporous items like routine metal instruments. The container is also compatible with pre-vacuum steam sterilization using a 4 minute cycle at 132° C for porous items and items with lumens or a 3 minute cycle for nonporous items like routine metal instruments. FlashPak® is recommended for sterilization of lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length). FlashPak® Model/Maximum Instrument Load Weight Recommendation: 9020 w/ 9020-08 Basket - Gravity 3 pounds (1.36 Kg) - Pre-Vacuum 3 pounds (1.36 Kg) ¥ 9030 w/ 9030-08 Basket - Gravity 10 pounds (4.55 Kg) - Pre-Vacuum 10 pounds (4.55 Kg) 9040 w/ 9040-08 Basket - Gravity 14 pounds (6.35 Kg) - Pre-Vacuum 14 pounds (6.35 Kg) 9050 w/ 9050-08 Basket - Gravity 16 pounds (7.27 Kg) - Pre-Vacuum 16 pounds (7.27 Kg)

Source page: https://510kreport.com/device/K141826
Methodology: https://510kreport.com/methodology