# K181472: AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products (Asp)
- Decided: Apr 23, 2019 after 323 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: 3 generations back to K922481 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103264: Endoscope Reprocessor Oer-Pro Model Oer-Pro, Olympus Medical Systems Corporation (2011) Summary page 4.
- K991709: Browne Cidex Opa Indicator, Albert Browne, Ltd. (1999) Summary page 4.
- K081427: Browne Opa Test Strip, STERIS Corporation (2008) Summary page 4.

## Indications for use
The ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor is indicated for use with high-level disinfectant ASP AERO OPA™ ortho-Phthalaldehyde Solution to achieve high-level disinfection of flexible semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the AER.

Source page: https://510kreport.com/device/K181472
Methodology: https://510kreport.com/methodology