# K082988: Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level Disinfectant

- Pathway: 510(k) (Traditional)
- Applicant: Medivators Reprocessing Systems
- Decided: Feb 13, 2009 after 129 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). 7 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063876: Modular Disinfection System (MDS) for Endoscope Reprocessing, Medivators Reprocessing Systems (2007) Summary page 3.
- K061899: Evotech Integrated Endoscope Disinfection System, Advanced Sterilization Products (2006) Summary page 3.
- K041984: Acecide High-Level Disinfectant and Sterilant, Best Sanitizers, Inc. (2005) Summary page 3.
- K960513: Peract 20 Liquid Sterilant, Minntech Corp. (1997) Summary page 3.

## Most influential descendants
- K152394: Rapicide PA High-Level Disinfectant Test Strips (2016), 2 descendants of its own
- K192228: CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant (2020), 1 descendant of its own
- K251035: DISINTEK™ PA Test Strips (2025), 0 descendants of its own
- K251048: Rapicide PA High-Level Disinfection Test Strip  Model Ref # = ML02-0118 (2025), 0 descendants of its own
- K233049: TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator (2023), 0 descendants of its own

## Recalls of this device
- Sep 21, 2026 · Class II · Z-0156-2027: If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the c
- Sep 21, 2026 · Class II · Z-0154-2027: If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the c
- Sep 21, 2026 · Class II · Z-0155-2027: If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the c
- 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, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the Advantage Plus system. Rapicide PA High Level Disinfectant is intended for use with the Advantage Plus Endoscope Reprocessing System to provide high level disinfection of endoscopes when used according to the directions for use. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (850ppm 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: High Level Disinfection — 5 minutes — 30(°C) — 850ppm

Source page: https://510kreport.com/device/K082988
Methodology: https://510kreport.com/methodology