# K172280: BH Sterilization Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Bh Medical Products Co., Ltd.
- Decided: Aug 3, 2018 after 371 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: 4 generations back to K990567 (1999). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070428: Medicom Self-Sealing Sterilization Pouch, A.R. Medicom, Inc. (2007) Summary page 4.

## Most influential descendants
- K191131: Solidence Multipockets (2022), 0 descendants of its own

## Indications for use
The BH sterilization pouch is intended to provide dentists with an effective method to enclose devices intended for sterilization in steam auto claves. The recommended pre-vacuum steam sterilization cycle parameters are 4 minutes at 132°C (270°F). The sterilization pouch maintains the enclosed devices up until 180 days post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. Only one instrument can be sterilized in one pouch and only instruments that are be metal, hinged, or knurled can be sterilized in the pouch.

Source page: https://510kreport.com/device/K172280
Methodology: https://510kreport.com/methodology