# K904518: Volumetric Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Kendall Mcgaw Laboratories, Inc.
- Decided: Oct 17, 1990 after 14 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 37 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
67 later devices descend from it; 2 cite it directly.
17 of 68 devices 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.

## Most influential descendants
- K994375: Horizon Light (2000), 65 descendants of its own
- K011975: Horizon Outlook with Dosecom (2001), 49 descendants of its own
- K042121: Spectrum and Spectrum with Master Drug Library (2004), 28 descendants of its own
- K133801: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (2014), 18 descendants of its own
- K023189: Vista Basic with FM System (2003), 16 descendants of its own

## Recalls of this device
- Aug 10, 2021 · Class II · Z-2552-2021: 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 5, 2013 · Class II · Z-2166-2013: Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corre
- Nov 24, 2009 · Not classified · Z-0675-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0676-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0691-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0697-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0698-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0703-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0679-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0680-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0690-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0694-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0709-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0710-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0712-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0713-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0715-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0716-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0717-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0681-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0682-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0683-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0687-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0688-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0689-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0692-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0693-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0711-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Nov 24, 2009 · Not classified · Z-0714-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi
- Mar 27, 2009 · Not classified · Z-1428-2009: Device defect is occlusion/no flow.
- Mar 27, 2009 · Not classified · Z-1431-2009: Device defect is occlusion/no flow.
- Jun 30, 2008 · Not classified · Z-2408-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2409-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2410-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2407-2008: incorrect burette was packaged with the product
- Apr 18, 2007 · Not classified · Z-0818-2007: Secondary infusion backs up into primary container.
- Apr 18, 2007 · Not classified · Z-0819-2007: Secondary infusion backs up into primary container.

Source page: https://510kreport.com/device/K904518
Methodology: https://510kreport.com/methodology