# K913661: Modified Volumetric Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Mcgaw, Inc.
- Decided: Dec 18, 1991 after 138 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 1 cites it directly.
6 of 18 devices 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.

## Most influential descendants
- K972678: Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration Sets (1997), 16 descendants of its own
- K062700: Infusomat Space Volumetric Infusion Pump System (2006), 15 descendants of its own
- K140838: IV Administration Set with Hand Pump (2014), 6 descendants of its own
- K083689: Infusomat Space Volumetric Infusion Pump System (2009), 4 descendants of its own
- K170595: IV Administration Sets (2017), 3 descendants of its own

## Recalls of this device
- Oct 29, 2025 · Class II · Z-0716-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0706-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0707-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0709-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Jun 17, 2024 · Class II · Z-2376-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie
- Jun 17, 2024 · Class II · Z-2404-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie
- Jun 17, 2024 · Class II · Z-2377-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie
- Aug 10, 2021 · Class II · Z-2556-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2551-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2555-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2546-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2557-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2544-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2550-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2545-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2554-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2558-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2549-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2547-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

Source page: https://510kreport.com/device/K913661
Methodology: https://510kreport.com/methodology