# K172677: Advantage Plus Pass-Thru

- Pathway: 510(k) (Traditional)
- Applicant: Medivators, Inc.
- Decided: Dec 19, 2017 after 105 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K914145 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082988: Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level Disinfectant, Medivators Reprocessing Systems (2009) Summary page 4.
- K102996: Medivators Advantage Plus Endoscope Reprocessor, Medivators Reprocessing Systems (2011) Summary page 4.

## Recalls of this device
- Nov 13, 2023 · Class II · Z-0617-2024: Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and m

## Indications for use
Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfect and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System. The Advantage Plus Pass-Thru Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Plus Detergent in its washing cycle at a concentration of 0.5%. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850 ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions – Contact Time: 5 minutes Temperature: 30°C MRC: 850ppm

Source page: https://510kreport.com/device/K172677
Methodology: https://510kreport.com/methodology