# K153540: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators - Pathway: 510(k) (Traditional) - Applicant: Safe Secure Packaging Co., Ltd. - Decided: Aug 4, 2016 after 238 days - Product code: FRG (Wrap, Sterilization) - Device class: 2 - Regulation: 21 CFR 880.6850 - Recalls of this device: 43 (0 Class I) - 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. 4 later devices descend from it; 3 cite it directly. 0 of 10 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K112591: Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process Indicators, Safe Secure Packaging Co., Ltd. (2012) Summary page 6. ## Most influential descendants - K180139: Safe Secure Sterilization Pouches and Rolls (2019), 1 descendant of its own - K250306: Chex-All Sterilization Pouches and Tubes (2025), 0 descendants of its own - K243431: Medicom Sterilization Pouch and Reel (2025), 0 descendants of its own - K242839: Safe Secure Sterilization Pouches and Rolls (2024), 0 descendants of its own ## Recalls of this device - Dec 2, 2020 · Class II · Z-0787-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of - Dec 2, 2020 · Class II · Z-0796-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Dec 2, 2020 · Class II · Z-0798-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Dec 2, 2020 · Class II · Z-0799-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Dec 2, 2020 · Class II · Z-0786-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Dec 2, 2020 · Class II · Z-0791-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Dec 2, 2020 · Class II · Z-0792-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Dec 2, 2020 · Class II · Z-0793-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Dec 2, 2020 · Class II · Z-0795-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Dec 2, 2020 · Class II · Z-0797-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Dec 2, 2020 · Class II · Z-0790-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Dec 2, 2020 · Class II · Z-0794-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Dec 2, 2020 · Class II · Z-0788-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Dec 2, 2020 · Class II · Z-0789-2021: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference - Jun 15, 2017 · Class II · Z-0744-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0745-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0748-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0749-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0753-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0761-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0764-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0770-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0751-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0752-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0758-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0759-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0760-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0762-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0765-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0766-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0771-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0747-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0750-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0757-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0763-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0768-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0743-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0746-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0754-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0755-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0756-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0767-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a - Jun 15, 2017 · Class II · Z-0769-2018: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch a ## Indications for use Safe Secure Paper Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using: • Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time • Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time • Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time • Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time • Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60oC (140oF). The device is not intended and has not been validated for sterilization of devices that contain lumens. The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide. The Tyvek version of the pouch is for EO sterilization only. If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10 -6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization and 24 months after EO sterilization. The maximum validated pouch load is 2.64 pounds (1.2kg). Source page: https://510kreport.com/device/K153540 Methodology: https://510kreport.com/methodology