# K082454: Micromyst Applicator, Model 20-5000

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Nov 7, 2008 after 73 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (1 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.
1 of 1 device in its family (counting itself) has 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) Confluent Surgical MicroMyst Applicator and Air Pump: named in the summary without a submission number

## Recalls of this device
- May 23, 2025 · Class I · Z-1961-2025: Lack of sterility assurance.

## Indications for use
The MicroMyst Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.

Source page: https://510kreport.com/device/K082454
Methodology: https://510kreport.com/methodology