# K241036: Autoclave Indicator Tape; EO Indicator Tape

- Pathway: 510(k) (Traditional)
- Applicant: Jiangmen New Era External Use Drug Co., Ltd.
- Decided: Dec 17, 2024 after 245 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
Longest line of descent: 3 generations back to K001649 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210553: Steam-Dot Process Indicator, Propper Manufacturing Co., Inc. (2021) Summary page 6.
- K210866: Steri-Dot Process Indicator, Propper Manufacturing Co., Inc. (2021) Summary page 6.

## Indications for use
Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed and unprocessed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile. The Autoclave Indicator Tape can be used in the following steam sterilization cycles: 1. Gravity: 121℃, 30 minutes 2. Vacuum assisted (pre-vacuum): 134℃, 4 minutes EO Indicator Tape is designed for use by a healthcare provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process and to distinguish between processed and unprocessed units or loads. The chemical indicator lines turn from Orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile. The EO Indicator Tape can be used in the following EO sterilization cycle: 55℃, 762mg/l EO, 40~80%RH, 4 hours exposure

Source page: https://510kreport.com/device/K241036
Methodology: https://510kreport.com/methodology