# K150477: 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Jul 2, 2015 after 128 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Indox Ethylene Oxide Indicator Tape: named in the summary without a submission number

## Indications for use
The tape is designed to secure packs wrapped with untreated woven (i.e., reusable 100% cotton and cotton/poly blends) and disposable non-woven, paper, paper/plastic, and spunbond polyolefin/plastic wraps. United States Use the EO indicator tape to demonstrate that packs have been exposed to one of the EO sterilization processes in the table below and to distinguish between processed and unprocessed packs. EO Gas Concentration Exposure Time Temperature Relative Humidity % 736 mg/ L 4.5 hours 38°C 40 – 80 % 736 mg/ L 1 hour 55°C 40 – 80 % 759 mg /L 4.5 hours 38°C 40 – 80 % 759 mg /L 1 hour 55°C 40 – 80 % 736 mg/ L 1 hour 54°C >35% 736 mg/ L 4.5 hours 38°C >35% 736 mg/ L 1 hour 55°C >35% 736 mg/ L 3 hours 37°C >35% 759 mg /L 1 hour 55°C >35% 759 mg /L 3 hours 37°C >35%

Source page: https://510kreport.com/device/K150477
Methodology: https://510kreport.com/methodology