# K981816: Cue Ambulatory Volumetric Infusion Pump - Pathway: 510(k) (Traditional) - Applicant: Becton Dickinson Curlin, LLC - Decided: Dec 4, 1998 after 196 days - Product code: FRN (Pump, Infusion) - Device class: 2 - Regulation: 21 CFR 880.5725 - Recalls of this device: 56 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K941984 (1994). 1 ancestor in all. No later device cites it as a predicate yet. 0 of 2 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K941984: Sabratek 6060 Homerun Volumetric Infusion Pump, Sabratek Corp. (1994) Summary page 1. - (no number) Abbott Ambulatory Infusion Manager Plus (Abbott AIM® Plus): named in the summary without a submission number ## Recalls of this device - Feb 27, 2019 · Class II · Z-2054-2019: Administration sets leaked at the filter. - Feb 27, 2019 · Class II · Z-2053-2019: Administration sets leaked at the filter. - Nov 10, 2017 · Class II · Z-0698-2018: Particulate found on the Curlin spike. - Nov 10, 2017 · Class II · Z-0697-2018: Particulate found on the Curlin spike. - Nov 10, 2017 · Class II · Z-0702-2018: Particulate found on the Curlin spike. - Nov 10, 2017 · Class II · Z-0699-2018: Particulate found on the Curlin spike. - Nov 10, 2017 · Class II · Z-0700-2018: Particulate found on the Curlin spike. - Nov 10, 2017 · Class II · Z-0701-2018: Particulate found on the Curlin spike. - Dec 23, 2015 · Class II · Z-0688-2016: Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out - Sep 26, 2012 · Class II · Z-0072-2013: This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers - May 18, 2012 · Not classified · Z-1671-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1668-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1662-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1664-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1661-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1660-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1672-2012: Moog Medical Device Group became aware on March 23, 2011 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1659-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1665-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1667-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1670-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1666-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1669-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - May 18, 2012 · Not classified · Z-1663-2012: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication bac - Mar 20, 2012 · Not classified · Z-1401-2012: Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. - Feb 28, 2011 · Not classified · Z-1867-2011: Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed. - Feb 28, 2011 · Not classified · Z-1868-2011: Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed. - Feb 28, 2011 · Not classified · Z-1870-2011: Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed. - Feb 28, 2011 · Not classified · Z-1869-2011: Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed. - Jan 24, 2011 · Not classified · Z-1452-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1448-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1449-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-2808-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1441-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1447-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1445-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1455-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1443-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1454-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1451-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1444-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-2809-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1440-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1453-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-2807-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1446-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1439-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1456-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1442-2011: Defect in tubing may trigger false Air-In-Line warning. - Jan 24, 2011 · Not classified · Z-1450-2011: Defect in tubing may trigger false Air-In-Line warning. ## Indications for use The CareMEDS™ infusion pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions. Any therapy should be overseen by a physician or a certified, licensed healthcare practitioner. The infusion pump can provide therapy to patients/users who are ambulatory and needed an alternative to receiving their medication in a restricted manner (hospital or clinic). Typically, these patients are capable of being given instruction for performing basic tasks in operating the pump and maintaining medical care for themselves, or are assisted in these tasks by having a caregiver closely by, or living with them. All patients and caregivers must be instructed in the use of the CareMEDS5™ by a qualified clinician and demonstrate an adequate level of proficiency in the use of the pump. The CareMED5™ is small, lightweight and is designed to have exceptional ease of use so theat after learning the pump features and basic of programming, the pump can be operated and can be customized to the specific needs of each individual patient without the need to constantly refer to the User’s Manual. Source page: https://510kreport.com/device/K981816 Methodology: https://510kreport.com/methodology