# K801036: Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: American Threshold Industries, Inc.
- Decided: Jun 4, 1980 after 33 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
329 later devices descend from it; 2 cite it directly.
0 of 330 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K082258: Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor (2008), 299 descendants of its own
- K110455: Kimberly-Clark Low Barrier, Astm 2100 Face Masks (2011), 289 descendants of its own
- K111402: KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300, Procedure Mask, Fluidshield Model (2011), 262 descendants of its own
- K131879: KC 300 Surgical Mask (2013), 185 descendants of its own
- K133070: SURGICAL FACE MASK (Ear Loops and Tie-on) (2015), 170 descendants of its own

## Recalls of this device
- Jun 3, 2003 · Not classified · Z-0944-03: The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.

Source page: https://510kreport.com/device/K801036
Methodology: https://510kreport.com/methodology