# K063535: Caption Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 26, 2007 after 96 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 K872565 (1987). 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)
- K881020: Surgical Sealant Dispenser (SSD), Micromedics, Inc. (1988) Summary page 1.
- K973510: Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML), Immuno-U.S., Inc. (1997) Summary page 1.

## Indications for use
For the simultaneous application of two non-homogeneous fluids to a treatment site.

Source page: https://510kreport.com/device/K063535
Methodology: https://510kreport.com/methodology