# K181174: Cardinal Health Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Dec 11, 2018 after 223 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: 9 generations back to K881471 (1988). 16 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151445: Cardinal Health Sterilization Wrap, Cardinal Health200, LLC (2015) Summary page 9.
- K151788: Cardinal Health Sterilization Wrap, Cardinal Health200, LLC (2015) Summary page 9.
- K161910: Cardinal Health Sterilization Wrap, Cardinal Health200, LLC (2017) Summary page 9.

## Most influential descendants
- K233777: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (2024), 1 descendant of its own
- K242208: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (2024), 0 descendants of its own
- K222151: Sterilization Wrap (2023), 0 descendants of its own

## Indications for use
The Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: • Gravity steam at 250°F/121°C for 30 minutes. • Pre-vacuum steam at 270°F/132°C for 4 minutes. • 100% ethylene oxide (EO) with a concentration of 725-735 mg/l at 131°F/55°C and 40%-80% relative humidity for 60 minutes. • Advanced Sterilization Products (ASP) STERRAD® 100S system. • Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles. • Advanced Sterilization Products (ASP) STERRAD® 100NX System, Standard, Flex, Express and Duo Cycles. • Advanced Sterilization Products (ASP) STERRAD® 200 System. • Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1, STERIS V-PRO® 1 Plus, STERIS V-PRO® maX and STERIS V-PRO® 60 Low Temperature Sterilization Systems. • TSO3 STERIZONE® VP4 System Cycle 1 (Refer to Table 5 for load) The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used. For gravity steam sterilization and pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less. For EO sterilization, the wrap has been validated for an aeration time of 8 hours at 55°C. Models CH400, CH500 and CH600 have been validated for EO sterilization of two lumens of 3 mm diameter or larger and 400 mm in length or less. All models of the Cardinal Health™ Sterilization Wrap have been validated for Advanced Sterilization Products (ASP) STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less. All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cycles in Table 1. All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® 200 in Table 1. All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the STERIS V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 cycles in Tables 2 and 3. The Cardinal Health™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and V-PRO® 60 sterilization cycles. All models of Cardinal Health™ Sterilization Wrap have been validated for use with the TSO3 STERIZONE® VP4 system with the intended loads as described in Table 4.

Source page: https://510kreport.com/device/K181174
Methodology: https://510kreport.com/methodology