# K102403: Sam Chest Seal with Vavle; Sam Chest Seal

- Pathway: 510(k) (Traditional)
- Applicant: Sam Medical Products
- Decided: Mar 3, 2011 after 191 days
- Product code: NAD (Dressing, Wound, Occlusive)
- Device class: 1
- Regulation: 21 CFR 878.4020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942757 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942757: Asherman Chest Bandage, Asherman Medical Products, LLC (1994) Summary page 1.
- K973511: Kendall Curity Petrolatum Gauze, Kendall Healthcare Products Co. Div.Of Tyco Health (1997) Summary page 1.

## Recalls of this device
- Jan 28, 2022 · Class II · Z-0789-2022: Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wo

## Indications for use
To be used as an occlusive wound dressing. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds, and to be used in emergency situations and to be left in place only while the patient is transported to the hospital.

Source page: https://510kreport.com/device/K102403
Methodology: https://510kreport.com/methodology