# P950009: Autopap (R) 300 QC Automatic Pap Screener/QC System

- Pathway: PMA
- Applicant: Bd Diagnostics
- Decided: Sep 29, 1995 after 217 days
- Product code: MNM (Reader, Cervical Cytology Slide, Automated)
- Device class: 3
- Recalls of this device: 1 (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
- Sep 21, 2018 · Class III · Z-0081-2019: The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating conditions when environmental temperatures are at or above 1

Source page: https://510kreport.com/device/P950009
Methodology: https://510kreport.com/methodology