# K171823: U&U Indicator tape and strip

- Pathway: 510(k) (Traditional)
- Applicant: U&U Medical Technology Co, Ltd.
- Decided: Feb 22, 2018 after 248 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: 1 generation back to K801057 (1980). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932129: 3M Autoclave Tapes, 3M Company (1994) Summary page 4.
- K801057: 3M Steam Sterilization Indicator, 3M Company (1980) Summary page 4.

## Indications for use
The U&U Sterilization indicator tapes and strips are designed to demonstrate that the unit or load has been exposed to a 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 off yellow to Dark brown/Black. Use the U&U Sterilization indicator tapes and strips in steam sterilization processes described below. 1. 121°C, 30 minutes; Gravity Steam 2. 132°C, 4 minutes; Dynamic Air Removal Steam 3. 135°C, 3 minutes; Dynamic Air Removal Steam

Source page: https://510kreport.com/device/K171823
Methodology: https://510kreport.com/methodology