# K831148: High Filtration Iso-Mask

- Pathway: 510(k) (Traditional)
- Applicant: Tecnol New Jersey Wound Care, Inc.
- Decided: Jul 17, 1984 after 466 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 2 (0 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.
0 of 1 device 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.

## Recalls of this device
- Nov 8, 2024 · Class II · Z-0729-2025: Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is p
- Nov 8, 2024 · Class II · Z-0728-2025: Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is p

Source page: https://510kreport.com/device/K831148
Methodology: https://510kreport.com/methodology