# K162362: PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Pms Tibbi Cihazlar Teknolojisi San VE Tic AS
- Decided: Oct 13, 2017 after 416 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 6.

## Indications for use
PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The recommended (and validated) sterilization cycle parameters for all models (Sterilization Pouches (FP) and Rolls(FL) with Chemical Indicator) are; For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes. Validated minimum dry time is 20 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 indicators on the exterior of the pouch and roll indicate by color change that the pouch has undergone either a steam or ethylene oxide sterilization process. Type1 steam indicator will change color from pink to brown after exposure to pre-vacuum steam sterilization process. Type 1 ethylene oxide indicator will change from turquoise to yellow after exposure to ethylene oxide sterilization process. As Worst Case Validated Load; general medical devices of stainless steel and devices with stainless steel lumens with the following internal diameter (ID) and Maximum Load weight and Maximum Lumen length can be processed in the validated steam and ETO sterilization cycles as follows; Table 1.Worst Case Validated Load and Lumen Claims. Pouch Size Product Code Max.Load Weight (lbs.) Max. lumen length (mm) Min. internal diameter (mm) Max # Lumens 50 x 200 mm FP 0520 0.062 50.8 mm 1.5 mm 1 200 x 300 mm FP 2030 0.516 200 mm 3.0 mm 1 250 x 300 mm FP 2530 0.520 200 mm 3.0 mm 1 500 x 600 mm FP 5060 3.344 400 mm 3.0 mm 1

Source page: https://510kreport.com/device/K162362
Methodology: https://510kreport.com/methodology