# K051291: Non-Sterile Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: A.R. Medicom, Inc.
- Decided: Sep 20, 2005 after 125 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K874608 (1987). 7 ancestors in all.
20 later devices descend from it; 7 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955513: Surgical Mask (Non-Sterile), United Medical Ent., Inc. (1996) 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
- 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
- K141875: Pasture 60S Surgical Mask (2015), 3 descendants of its own

## Recalls of this device
- Dec 21, 2023 · Class II · Z-1148-2024: Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- Dec 21, 2023 · Class II · Z-1146-2024: Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- Dec 21, 2023 · Class II · Z-1147-2024: Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- Oct 11, 2019 · Class II · Z-0494-2020: Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower p
- Oct 11, 2019 · Class II · Z-0495-2020: Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower p

## Indications for use
The medical/surgical masks listed below are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid, and particulate aerosol transfer.

Source page: https://510kreport.com/device/K051291
Methodology: https://510kreport.com/methodology