# K243433: enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Dec 2, 2024 after 27 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K161683 (2016). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230930: enspire 3000 Cleaning and Liquid Chemical Sterile Processing System, STERIS Corporation (2023) Summary page 6.

## Indications for use
The enspire TM 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semicritical, heat sensitive medical devices such as flexible endoscopes and their accessories. The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire m 3000 Series Processor. The enspire TM 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medical devices. It automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 550C and rinses the load with 0.2-micron filtered water.

Source page: https://510kreport.com/device/K243433
Methodology: https://510kreport.com/methodology