# K061864: Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560

- Pathway: 510(k) (Traditional)
- Applicant: Dukal Corp.
- Decided: Sep 15, 2006 after 74 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K874608 (1987). 8 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051291: Non-Sterile Surgical Mask, A.R. Medicom, Inc. (2005) Summary page 1.
- K040333: Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without Visors, Ties and Earloops, Valumax Intl., Inc. (2004) Summary page 1.

## Most influential descendants
- K111559: Surgical Masks (2011), 4 descendants of its own
- K201137: Asept Surgical Face Mask (2020), 3 descendants of its own
- K203200: Disposable Medical Surgical Face Mask (2021), 1 descendant of its own
- K210643: Disposable Surgical Face Mask (2021), 0 descendants of its own
- K203174: Disposable Medical Mask (2021), 0 descendants of its own

## Indications for use
The Dukal medical / surgical mussks are indicated as a protective nose and mouth coveting for healthcare workers and patients involved in medical aud surgical procedures. The masks are indi-:rled in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer. This covers our current catalog numbers (these numbers can, change with updated revisions to the catdlog):

Source page: https://510kreport.com/device/K061864
Methodology: https://510kreport.com/methodology