# K955513: Surgical Mask (Non-Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: United Medical Ent., Inc.
- Decided: Apr 22, 1996 after 140 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
No predicates in its family tree.
21 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K051291: Non-Sterile Surgical Mask (2005), 20 descendants of its own
- K092580: Tidi Facemask (2010), 9 descendants of its own
- K061864: Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560 (2006), 6 descendants of its own
- K111559: Surgical Masks (2011), 4 descendants of its own
- K201137: Asept Surgical Face Mask (2020), 3 descendants of its own

Source page: https://510kreport.com/device/K955513
Methodology: https://510kreport.com/methodology