# K910515: Freedom Mark Iii Surgical Helmet System

- Pathway: 510(k) (Traditional)
- Applicant: Stackhouse Assoc.
- Decided: May 6, 1991 after 90 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 15 (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
- Mar 10, 2015 · Class II · Z-1339-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Mar 10, 2015 · Class II · Z-1347-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Mar 10, 2015 · Class II · Z-1338-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Mar 10, 2015 · Class II · Z-1346-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Mar 10, 2015 · Class II · Z-1349-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Mar 10, 2015 · Class II · Z-1343-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Mar 10, 2015 · Class II · Z-1340-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Mar 10, 2015 · Class II · Z-1345-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Mar 10, 2015 · Class II · Z-1342-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Mar 10, 2015 · Class II · Z-1344-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Mar 10, 2015 · Class II · Z-1341-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Mar 10, 2015 · Class II · Z-1337-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Mar 10, 2015 · Class II · Z-1348-2015: This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packagi
- Sep 13, 2005 · Not classified · Z-0001-06: The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
- Sep 13, 2005 · Not classified · Z-0002-06: The packaging may be compromised such that sterility of the hoods cannot be guaranteed.

Source page: https://510kreport.com/device/K910515
Methodology: https://510kreport.com/methodology