# K874746: Sealflex Mask

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Dec 21, 1987 after 33 days
- Product code: BSJ (Mask, Gas, Anesthetic)
- Device class: 1
- Regulation: 21 CFR 868.5550
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has 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.

## Recalls of this device
- Sep 12, 2011 · Class I · Z-1058-2013: The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

Source page: https://510kreport.com/device/K874746
Methodology: https://510kreport.com/methodology