# K070814: Modification to Confluent Surgical Micromyst Applicator and Air Pump

- Pathway: 510(k) (Special)
- Applicant: Confluent Surgical,Inc
- Decided: May 30, 2007 after 65 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K964597 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050998: Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-a-6063, Confluent Surgical,Inc (2005) Summary page 1.

## Indications for use
The Confluent Surgical MicroMyst Applicator and Air Pump are indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site.

Source page: https://510kreport.com/device/K070814
Methodology: https://510kreport.com/methodology