# K230137: Reliance® Fusion Sterilization Wraps

- Pathway: 510(k) (Traditional)
- Applicant: Ahlstrom-Munksjo Nonwovens, LLC
- Decided: Dec 7, 2023 after 323 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: 7 generations back to K881471 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171533: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap, Ahlstrom Nonwovens, LLC (2017) Summary page 5.

## Indications for use
Reliance® Fusion Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following: • Pre-vacuum Steam 270°F/132°C for 4 minutes o Dry time of 12 minutes for Fusion Light o Dry time of 20 minutes for Fusion Heavy o Pre-vacuum steam sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in length or less. • 100% Ethylene Oxide (EO) with a concentration of 725-759 mg/L @ 131°F/55°C and 40% - 70% relative humidity for 60 minutes o Aeration time of 8 hours at 55oC o Ethylene oxide sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in length or less. Table 1: Reliance® Fusion Models and Load Recommendations Wrap Code | Material Type | Intended Load | Wrap Sheet Size, Maximum Recommended Wrapped Package Content Weight: Pre-Vacuum Steam and Ethylene Oxide¹ Reliance® Fusion Light | Outer SMS / Inner Absorbent Wetlaid Layer | Light to Moderate Weight Package (e.g. general use medical instruments) | 1.8 lb (12" x 12"); 2.0 lb (15" x 15"); 2.4 lb (18" x 18"); 3.2 lb (24" x 24"); 4.3 lb (30" x 30"); 5.7 lb (36" x 36"); 6.7 lb (40" x 40"); 9 lb (48" x 48"); 9 lb (54" x 54"); 9 lb (54" x 72") Reliance® Fusion Heavy | Outer SMS / Inner Absorbent Wetlaid Layer | Very Heavy Weight Package (e.g. general use medical instruments) | 1.8 lb (12" x 12"); 2.6 lb (15" x 15"); 3.7 lb (18" x 18"); 6.4 lb (24" x 24"); 9.9 lb (30" x 30"); 14.2 lb (36" x 36"); 17.5 lb (40" x 40"); 25 lb (48" x 48"); 25 lb (54" x 54"); 25 lb (54" x 72") ¹ It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. In addition, it is recommended to not exceed the number, weight, and size of individual content types that were validated for Reliance® Fusion Sterilization Wraps (i.e. wrapped contents).

Source page: https://510kreport.com/device/K230137
Methodology: https://510kreport.com/methodology