# K022209: Alaris Medical Infusion System Administration Sets

- Pathway: 510(k) (Special)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Aug 6, 2002 after 29 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 8 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K221327: BD Alaris™ Pump Infusion Sets (2023), 1 descendant of its own
- K250325: BD Alaris Pump Infusion Set (2025), 0 descendants of its own
- K041919: Perfudrop Air M-P with Needle 20 G, Model 48451606 (2004), 0 descendants of its own

## Recalls of this device
- Aug 19, 2026 · Class I · Z-3080-2026: Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
- Sep 11, 2025 · Class I · Z-0035-2026: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, a
- Jul 8, 2025 · Class I · Z-2180-2025: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, a
- Apr 18, 2024 · Class II · Z-1944-2024: Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.
- Oct 11, 2023 · Class II · Z-0349-2024: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
- Oct 11, 2023 · Class II · Z-0350-2024: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
- Oct 11, 2023 · Class II · Z-0351-2024: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
- Aug 10, 2006 · Not classified · Z-1484-06: This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce.

## Indications for use
The following ALARIS Medical Infusion Systems are intended for use in today’s growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize inhsion systems for the delivery of fluids, medications, blood and blood products: IVAC? Signature Edition@Infusion Pumps and Administration Sets. IVAC? MedSystem III@Multi-Channel Inhsion Pump and IVAC MedSystem I I P Multi-Channel Infusion Pump with DLE and Administration Sets. IMED@Gemini Infusion Pumps/Controllers and Administration Sets. ALARIS Medical Medley” Medication Safety System and Administration Sets. IVAC@,IMED@,and ALARIS@Gravity, Extension, Components, and Secondary Administration Sets.

Source page: https://510kreport.com/device/K022209
Methodology: https://510kreport.com/methodology