# P810040: Superstat

- Pathway: PMA
- Applicant: Superstat Corp.
- Decided: Jan 29, 1982 after 177 days
- Product code: LMF (Agent, Absorbable Hemostatic, Collagen Based)
- Device class: 3
- Regulation: 21 CFR 878.4490
- Recalls of this device: 13 (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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 24, 2012 · Class II · Z-0331-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag
- Oct 24, 2012 · Class II · Z-0335-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag
- Oct 24, 2012 · Class II · Z-0337-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag
- Oct 24, 2012 · Class II · Z-0338-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag
- Oct 24, 2012 · Class II · Z-0343-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag
- Oct 24, 2012 · Class II · Z-0332-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag
- Oct 24, 2012 · Class II · Z-0340-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag
- Oct 24, 2012 · Class II · Z-0341-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag
- Oct 24, 2012 · Class II · Z-0333-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag
- Oct 24, 2012 · Class II · Z-0334-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag
- Oct 24, 2012 · Class II · Z-0336-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag
- Oct 24, 2012 · Class II · Z-0339-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag
- Oct 24, 2012 · Class II · Z-0342-2013: The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collag

Source page: https://510kreport.com/device/P810040
Methodology: https://510kreport.com/methodology