# K993042: Medivators 5 Minute High-Level Disinfectant

- Pathway: 510(k) (Traditional)
- Applicant: Medivators, Inc.
- Decided: Aug 17, 2000 after 342 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Wavicide-01 Solution: named in the summary without a submission number

## Most influential descendants
- K051305: CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5 High-Level Disinfectant, Model TD-5 (2005), 9 descendants of its own
- K120306: Rapicide Opa-28 (2012), 3 descendants of its own
- K103059: Trophon (2011), 3 descendants of its own
- K173865: trophon2 (2018), 2 descendants of its own
- K160921: CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant (2016), 2 descendants of its own

## Indications for use
Refer to the package nsert for mare detailed information about product ysage, matenal compatbility, and other subjects. STERILIZATION: Rapicide™ High Level Disinfectant and Sterilant is intended to be used for the automated sterilization of clean, heat sensitive, critical medical equipment for which alternative methods of sterilization are not suitable. Critical medical devices are those that contact normally sterile areas of the body. Critical medical devices must be sterilized. Rapicide™ High Level Disinfectant and Sterilant is a sterilant when used or reused, in a legally marketed Automated Endoscope Reprocessor according 1o Directions for Use, at @ minimum recommended concentratian (MRC) of 1.5% glutaraldehyde at 35°C (95°F), not to exceed 28 days, with @ minimum coniact or immersion time of at least 7 hours and 40 minutes. HIGH-LEVEL DISINFECTION: Rapiciae™ High Level Disinfectant and Sterilant is intended to be used for the autormnated high level disinfection of clean, heat sensitive, semi-critical medical devices for which sterilization is not practical. Semi-cntical medical devices may be sterilized or high-level disinfected. Semi-critical medical devices are those that contact mucous membranes or ather body surfaces not normally considered sterile. Rapicide™ High Level Disinfectant and Sterilant is a high-level disinfectant when used or reused, in a legally marketed Automated Endoscope Reprocessor according to Directions for Use, at a minimum recommended concentration (MRC) of 1.5% glutaraldehyde at 35°C (35°F), not to exceed 28 days, with a minimum contact or immersion tme of at least 5 minutes.

Source page: https://510kreport.com/device/K993042
Methodology: https://510kreport.com/methodology