# K141412: Sterilucent Self-Seal Sterilization Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Gs Medical Packaging, Inc.
- Decided: Dec 3, 2014 after 188 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 K771032 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070765: Vis-U-All II Self Seal Pouch, STERIS Corporation (2007) Summary page 6.

## Indications for use
The Sterilucent Self-Seal Sterilization Pouch is intended to be used to enclose medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The pouches are intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen Cycles. Pouch Models and Sizes Catalog No. Size SL264 3.5” x 9” SL265 4” x 22” SL266 5.25” x 10” SL267 5” x 15” SL268 7.5” x 13” SL269 12” x 15” SL270 12” x 18” The PSD-85 Lumen Cycle has been validated to sterilize a load of up to ten (10) pounds (combined pouch and wrapped tray load) containing a maximum of ten (10) single channel stainless steel lumens per load with the following dimensions: • An inside diameter of 1 mm or larger and a length of 60 mm or shorter; • An inside diameter of 2 mm or larger and a length of 250 mm or shorter; • An inside diameter of 3 mm or larger and a length of 350 mm or shorter. The PSD-85 Non-Lumen Cycle has been validated to sterilize a load of up to 25 pounds (combined pouch and wrapped tray load). The maximum validated pouch load is two (2) pounds.

Source page: https://510kreport.com/device/K141412
Methodology: https://510kreport.com/methodology