# K152669: PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)

- Pathway: 510(k) (Traditional)
- Applicant: Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std
- Decided: Jan 15, 2016 after 120 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: 5 generations back to K990567 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102158: Sigma Sterilization Pouch & Roll, Sigma Medical Supplies Corp. (2011) Summary page 4.

## Indications for use
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization with steam or ethylene oxide (EO) applying the below validated sterilization cycle parameters. The indicated sterilization parameters for either steam or EO are the only validated sterilization parameters to be used/applied. The recommended (and validated) sterilization cycle parameters are; • For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes. • For EO sterilization; 100% ethylene oxide (EO) with a concentration of 725mg/l at 55 degrees C and 50-80% relative humidity for 60 minutes. Aeration time is 8 hours. Chemical process indicator on the exterior of the pouch indicates by color change that the pouch has undergone either a steam or ethylene oxide sterilization process. After the sterilization process is completed the sterility of the enclosed medical device is maintained for 30 days.

Source page: https://510kreport.com/device/K152669
Methodology: https://510kreport.com/methodology