# K972678: Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Mcgaw, Inc.
- Decided: Oct 7, 1997 after 83 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K820133 (1982). 12 ancestors in all.
16 later devices descend from it; 1 cites it directly.
6 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915522: Flo-Gard (R) 6201, Baxter Healthcare Corp (1992) Summary page 2.
- K941244: Safeline System Turn Lock Cannula, Mcgaw, Inc. (1994) Summary page 2.
- K931377: Safeline System IV Administration Sets & Component, Mcgaw, Inc. (1994) Summary page 2.
- K922637: Horizon Pump Y-Type Blood Set, Mcgaw, Inc. (1993) Summary page 2.
- K921860: Modification to IV Spike, Mcgaw, Inc. (1992) Summary page 2.
- K913661: Modified Volumetric Infusion Pump, Mcgaw, Inc. (1991) Summary page 2.
- K904518: Volumetric Infusion Pump, Kendall Mcgaw Laboratories, Inc. (1990) Summary page 2.
- K896292: 1.2 Micron Filter with IV Set, Kendall Mcgaw Laboratories, Inc. (1989) Summary page 2.
- K860157: Nitroglycerin Intravascular Administration Set, Quest Medical, Inc. (1986) Summary page 2.
- K840248: IV-Filter, Tri-Med, Inc. (1984) Summary page 2.
- K840212: Concentrated Platelet Admin. Set, American Mcgaw (1984) Summary page 2.
- K820133: Mcgaw Fat Emulsion Set, American Mcgaw (1982) Summary page 2.
- (no number) Standard Baxter solution administration sets intended for use with the Flo-Gard 6201 Pump: named in the summary without a submission number

## Most influential descendants
- 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
- K121613: Agilia Infusion System (2013), 2 descendants of its own

## Indications for use
The Millennium CRT™ Infusion Pump and Millennium CRT™ Infusion Pump Administration Sets create an infusion system intended for parenteral and enteral administration. This includes, but is not limited to standard L.V. fluids (large volume parenterals and small volume parenterals), blood, blood components, nitroglycerin, Total Parenteral Nutrition (TPN), lipids, enteral fluids, 1.V. drugs such as paclitaxel and other chemotherapeutic agents, and epidural administration of anesthetic and analgesicdrugs. The pump is capable of drawing fluid from containers or syringes and administering the fluid to a patient through the administration set. The Millennium CRT™ Infusion Pump Administration Sets can also be used as stand-alone devices without the Millennium CRT™ Infusion Pump. When used without the Millennium CRT™ Infusion Pump, the Millennium CRT™ Infusion Pump Administration Sets are also intended for parenteral and enteral administration. However, administration of these fluids is accomplished through gravity infusion. When used for gravity infusion, these sets may be used for administration of standard LV. fluids (large volume parenterals and small volume parenterals), blood, blood components, lipids, nitroglycerin, TPN, 1.V. drugs mcludmg paciltaxel and other chemotherapeutic agents, and -enteral fluids. The Millennium CRT™ pump and associated administration sets are intended for, but are not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Millennium CRT™ Infusion Pump is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and validation of the Millennium CRT™ Infusion Pump is performed by the trained healthcare provider per a physician’s order.

Source page: https://510kreport.com/device/K972678
Methodology: https://510kreport.com/methodology