# K973485: Clearview Blower/Mister

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Dec 8, 1997 after 84 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922083 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922083: Rmi Surgiccal Site Visualization Wand, Research Medical, Inc. (1993) Summary page 1.

## Recalls of this device
- Mar 19, 2024 · Class II · Z-1794-2024: Potential for unsealed sterile packing.

## Indications for use
This device is intended for use during procedures when a wound or surgical site must be cleared by non-contact means for improved visibility at the site.

Source page: https://510kreport.com/device/K973485
Methodology: https://510kreport.com/methodology