# K160755: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Ahlstrom Nonwovens, LLC
- Decided: Jul 27, 2016 after 131 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 K881471 (1988). 9 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082177: Kimguard One-Step Sterilization Wrap, Kimberly-Clark Corp. (2009) Summary page 6.
- K082554: Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600, Kimberly-Clark Corp. (2009) Summary page 6.
- K091685: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600, Kimberly-Clark Corp. (2009) Summary page 6.
- K141071: Kimguard One-Step Sterilization Wrap, Kimberly-Clark Health Care (2014) Summary page 6.
- K092167: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600, Kimberly-Clark Corp. (2009) Summary page 6.
- K112805: Kimguard One-Step Sterilization Wrap, Kimberly-Clark Corp. (2012) Summary page 6.
- K113806: Kimguard One Step Sterilization Wrap, Kimberly-Clark Health Care (2013) Summary page 6.
- K141612: Kimguard One-Step Sterilization Wrap, Kimberly-Clark Health Care (2014) Summary page 6.

## Most influential descendants
- K171533: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap (2017), 2 descendants of its own
- K182656: JAMBRO Single Core A Sterilization wrap (2019), 1 descendant of its own
- K240438: CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) (2024), 0 descendants of its own
- K230137: Reliance® Fusion Sterilization Wraps (2023), 0 descendants of its own
- K223600: Sterilization Wrap (2023), 0 descendants of its own

## Indications for use
Ahlstrom Reliance® Tandem and Solo 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 • Gravity Steam 250°F/121°C for 30 minutes • 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% - 80% relative humidity for 60 minutes • Advanced Sterilization Products (ASP) STERRAD® 100S • Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles) • STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles) The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used. Pre-Vacuum Steam Sterilization: • Validated for dry time of 20 minutes for Models T100/S100, T200/S200, T300/S300. • Validated for dry time of 30 minutes for Models T400/S400, T500/S500, T600/S600. • All models of Reliance® Tandem and Solo validated for pre-vacuum steam sterilization with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model. Gravity Steam Sterilization: • Validated for dry times of 20 minutes for Models T100/S100, T200/S200, T300/S300. • Validated for dry times of 30 minutes for Models T400/S400. • Models T100/S100, T200/S200, T300/S300, T400/S400 of Reliance® Tandem and Solo validated for gravity steam sterilization with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model. • Models T500/S500 and T600/S600 are not validated for use for gravity steam sterilization. Ethylene Oxide Sterilization: • Validated for aeration time of 8 hours at 55°C • All models of Reliance® Tandem and Solo validated for ethylene oxide sterilization with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model. Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization • All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100S sterilization with stainless steel lumens (2 mm inside diameter or larger and a length of 250mm or less) as part of the load with a maximum weight of 10.7lbs dependent on the model. Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization • All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100NX sterilization cycles detailed in Table 1. Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100NX Cycles Advanced Sterilization Products (ASP) STERRAD® System and Cycle Intended Load 100NX Standard Cycle Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: • An inside diameter of 0.7mm or larger and a length of 500mm or shorter of single-channel stainless steel lumens. 100NX Flex Cycle One or two single-channel flexible endoscopes with or without a silicone mat. Flexible endoscope may contain: • A single channel Teflon/PE/PTFE lumen with an inside diameter of 1 mm or larger and a length of 850mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle) 100NX Express Cycle Non-lumened reusable metal and non-metal medical devices requiring surface sterilization, or sterilization of mated stainless steel and titanium surfaces, and rigid or semi-rigid endoscopes without lumens. STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems • All models of Reliance® Tandem and Solo Sterilization Wraps have been validated for use with STERIS V-PRO® cycles detailed in Table 2. • Reliance® Tandem and Solo Sterilization Wraps were validated to be effectively aerated during the pre-programmed STERIS Amsco V-PRO® Sterilization Cycles. Table 2: Validated STERIS Amsco® V-PRO Cycles STERIS Amsco® V-PRO Cycle Intended Load Lumen Cycle Reusable metal and non-metal medical devices, including up to 20 stainless steel lumens with dimensions of 3.0mm diameter or larger and a length of 400mm or shorter. Non Lumen Cycle Non lumened reusable metal and non-metal medical devices. Flexible Cycle Single lumen surgical flexible endoscopes and bronchoscopes in the following load configuration: 1.) One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat. The flexible endoscope having an inside diameter of 1 mm or larger and a length of 850 mm or shorter. 2.) An additional tray containing non-lumened medical devices.

Source page: https://510kreport.com/device/K160755
Methodology: https://510kreport.com/methodology