# K905498: Stat 2 IV Pumpette

- Pathway: 510(k) (Traditional)
- Applicant: The Master Medical Corp.
- Decided: Apr 16, 1991 after 130 days
- Product code: LDR (Controller, Infusion, Intravascular, Electronic)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 5 (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
- Jun 19, 2017 · Class II · Z-0804-2018: Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
- Apr 15, 2011 · Not classified · Z-0629-2012: 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-0634-2012: 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-0683-2012: 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-0682-2012: 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/K905498
Methodology: https://510kreport.com/methodology