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SafePass Sterilization Pouch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K973981

by Adroit Medical Systems, Inc.

Identifiers

510(k) Number
K973981 FDA 510(k)
FDA Product Code
KCT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6850 FDA 510(k)
Regulation Number
880.6850 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SafePass Sterilization Pouch is a pre-formed, partially folded pouch designed for enclosing medical devices, kits, or instruments during steam sterilization. Constructed from previously cleared sterilization wrap material, it features a patented folding system with a pre-cuffed opening to ensure secure containment. Its primary function is to protect sterile barrier integrity while facilitating efficient sterilization processes in clinical settings.

This device is supplied as a single-use pouch, intended for use in hospital or healthcare environments where steam sterilization is required. It requires no additional preparation beyond inserting items and performing final folds to secure the opening. The pouch is classified under product code KCT and has received FDA 510(k) clearance (K973981) as substantially equivalent to a predicate device. No specific MRI safety or sterility beyond standard sterilization processes is indicated.

Frequently asked questions

What is the SafePass Sterilization Pouch designed for?

The SafePass Sterilization Pouch is specifically designed to enclose medical devices, kits, or instruments during steam sterilization. Its pre-formed, partially folded structure and pre-cuffed opening ensure secure containment while protecting the sterile barrier integrity of the enclosed items. This makes it ideal for clinical settings where steam sterilization is required, such as hospitals or healthcare facilities.

How is the SafePass Sterilization Pouch supplied and prepared for use?

The pouch is supplied as a single-use item, ready for immediate use. No additional preparation is required beyond inserting the medical devices, kits, or instruments into the pouch. After insertion, you simply perform the final folds to secure the opening, ensuring a tight seal for sterilization.

Is the SafePass Sterilization Pouch reusable or intended for single-use?

The SafePass Sterilization Pouch is explicitly intended for single-use only. This design choice ensures optimal sterility and prevents cross-contamination between sterilization cycles, aligning with best practices for maintaining sterile environments in healthcare settings.

What materials is the SafePass Sterilization Pouch made from?

The pouch is constructed from previously cleared sterilization wrap material, which is designed to withstand steam sterilization processes while maintaining its protective properties. The specific material composition is not detailed in the provided data, but it is engineered to meet the requirements for steam sterilization and sterile barrier integrity.

How should the SafePass Sterilization Pouch be stored?

While the provided data does not specify storage conditions, standard practice for single-use sterilization pouches like this one typically involves storing them in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. Ensure the pouch remains sealed until use to preserve its sterility and functionality.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K973981 FDA 510 (k) - SAFEPASS STERILIZATION POUCH, SAFEPASS STERILIZATION POUCH (K973981) — FDA 510(k) | Innolitics, Adroit Medical Systems, Inc. FDA 510 (k) Products (1992-2008), 510 (k) K973981 — SAFEPASS STERILIZATION POUCH — RegDataLab, K973981 FDA 510 (k) - SAFEPASS STERILIZATION POUCH

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Adroit Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K973981 24 fields · synced Oct 5, 2026