# K070529: Aff (Mark I) Volumetric Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Definitive Medical Technologies, Ltd.
- Decided: May 8, 2007 after 74 days
- Product code: FRN (Pump, Infusion)
- 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
Longest line of descent: 1 generation back to K915522 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003029: Infusomat P, B.Braun Medical, Inc. (2000) Summary page 1.
- K950766: Sigma 8000 and Sigma 8002, Sigma Intl. General Medical Apparatus, Inc. (1995) Summary page 1.
- K915522: Flo-Gard (R) 6201, Baxter Healthcare Corp (1992) Summary page 1.

## Recalls of this device
- Jun 14, 2016 · Class II · Z-2220-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specificati
- Jun 14, 2016 · Class II · Z-2219-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specificati
- Oct 1, 2015 · Class II · Z-0242-2016: The device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the Total Volume L
- Feb 17, 2014 · Class II · Z-1122-2014: WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction.
- Jun 17, 2010 · Not classified · Z-0307-2011: Pump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound.

## Indications for use
The AFF (MARK I) Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.

Source page: https://510kreport.com/device/K070529
Methodology: https://510kreport.com/methodology