# K061430: System 83 Plus Miniflex Washer-Disinfector

- Pathway: 510(k) (Traditional)
- Applicant: Custom Ultrasonics
- Decided: Jan 12, 2007 after 234 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Dec 12, 2005 · Not classified · Z-0770-2007: The device was marketed without a 510k

## Indications for use
The MinFlex Washer-Disinfector is intended for washing and high-level disinfecting one or two submersible flexible endoscopes that do not contact normally sterile areas of the body and that feature either no internal channel (i.e., a probe) or one internal channel. The types of flexible endoscopes for which the MinFlex Washer-Disinfector is labeled include those that are used to examine, diagnose, and treat diseases of the pulmonary tract, urinary tract, uterine cavity, and ear, nose, and throat (ENT) cavities.

Source page: https://510kreport.com/device/K061430
Methodology: https://510kreport.com/methodology