# K102996: Medivators Advantage Plus Endoscope Reprocessor

- Pathway: 510(k) (Traditional)
- Applicant: Medivators Reprocessing Systems
- Decided: Jan 13, 2011 after 98 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914145 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061899: Evotech Integrated Endoscope Disinfection System, Advanced Sterilization Products (2006) Summary page 2.

## Most influential descendants
- K172677: Advantage Plus Pass-Thru (2017), 0 descendants of its own

## Recalls of this device
- Jun 13, 2024 · Class II · Z-2537-2024: IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from
- Jun 13, 2024 · Class II · Z-2538-2024: IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from
- Jun 13, 2024 · Class II · Z-2536-2024: IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from
- 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
Medivators Advantage Plus Endoscope Reprocessing System tests, cleans, disinfects and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of beat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is not required prior to placement in the Advantage Plus system. The scopes must be precleaned immediately after use. The Advantage Plus 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 Detergent in its cleaning 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 B5Oppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used in the Advantage Plus System under the following contact conditions: Contact Time: 5 minutes Temperature: 300C MRC: S5Oppm

Source page: https://510kreport.com/device/K102996
Methodology: https://510kreport.com/methodology