# K964844: Conmed: Stat 2 and Stat 2 Pumpette Extension Sets and Masterflow and Masterflow Pumpette Primary Sets

- Pathway: 510(k) (Traditional)
- Applicant: Conmedcorp
- Decided: Mar 24, 1997 after 111 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 12 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jun 19, 2017 · Class II · Z-0805-2018: Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
- Apr 15, 2011 · Not classified · Z-0636-2012: ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the dev
- Apr 15, 2011 · Not classified · Z-0630-2012: ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the dev
- Apr 15, 2011 · Not classified · Z-0631-2012: ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the dev
- Apr 15, 2011 · Not classified · Z-0633-2012: ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the dev
- Apr 15, 2011 · Not classified · Z-0684-2012: ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that th
- Apr 15, 2011 · Not classified · Z-0632-2012: ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the dev
- Apr 15, 2011 · Not classified · Z-0635-2012: ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the dev
- Apr 15, 2011 · Not classified · Z-0685-2012: ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that th
- Apr 15, 2011 · Not classified · Z-0687-2012: ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that th
- Apr 15, 2011 · Not classified · Z-0688-2012: ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that th
- Apr 15, 2011 · Not classified · Z-0686-2012: ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that th

Source page: https://510kreport.com/device/K964844
Methodology: https://510kreport.com/methodology