Atlas FDA

CUE AMBULATORY VOLUMETRIC INFUSION PUMP

FDA 510(k) clearance K981816 · decided 1998-12-04

Clearance details

K-number
K981816
Device name
CUE AMBULATORY VOLUMETRIC INFUSION PUMP
Applicant
Becton Dickinson Curlin, LLC
Decision
Substantially Equivalent
Date received
1998-05-22
Decision date
1998-12-04
Days to decision
196 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Huntington Beach, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Becton Dickinson Curlin

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection (K253703)Deka R&D Corp2026-07-24
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (K252015)Koru Medical Systems, Inc.2026-01-28
SIGMA Spectrum Infusion Pump with Master Drug Library (K251640)Baxter Healthcare Corporation2025-07-28
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636)Baxter Healthcare Corporation2025-07-28
MRidium 3870 MRI Infusion Pump System (3870) (K242752)Iradimed Corporation2025-05-28
BD Alaris Infusion System with Guardrails Suite MX (K243855)Carefusion 303, Inc.2025-04-25
Plum Solo™ Precision IV Pump (K242114)Icu Medical, Inc.2025-04-02
Plum Duo™ Precision IV Pump (K242115)Icu Medical, Inc.2025-04-02
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (K250357)Deka Research & Development Corp.2025-03-11
Remunity 2.0 Pump for Remodulin (treprostinil) Injection (K241736)Deka Research and Development Corp.2025-01-16
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) (K242735)Belmont Medical Technologies2024-12-23
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets (K242660)Zevex, Inc.2024-10-03

Recalls involving this device

RecordFirmDate
MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag recall (Z-2053-2019)Zevex Incorporated (dba MOOG Medical Devices Group)2019-07-23
MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented B recall (Z-2054-2019)Zevex Incorporated (dba MOOG Medical Devices Group)2019-07-23
Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System inclu recall (Z-0688-2016)MOOG Medical Devices Group2016-02-11
***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infu recall (Z-0072-2013)MOOG Medical Devices Group2012-10-17
Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly, product cod recall (Z-1659-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly, product recall (Z-1660-2012)MOOG Medical Devices Group2012-05-30
Epidural Admin Set with Non-Vented Bag Spike and 0.2 Micron Filter Package Assembly, produ recall (Z-1661-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly, product recall (Z-1662-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly, product recall (Z-1663-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly, product recall (Z-1664-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly, product recall (Z-1665-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Microbore Admin Set with Female Male Luer Locks and Y-Site with Check Valve Packa recall (Z-1666-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Epidural Yellow Striped Tubing Admin Set with Vented Vial Spike and 0.2 Micron Fi recall (Z-1667-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Epidural Admin Set with 0.2 Micron Filter Non-Vented Bag Spike ASV Packaged, prod recall (Z-1668-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged, product code: 34 recall (Z-1669-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Admin Set Non-Vented Spike and 1.2 Micron Filter ASV Packaged Assembly, product c recall (Z-1670-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Microbore Admin Set with Non-Vented Spike and Needleless Injection Port Positive recall (Z-1671-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly, product recall (Z-1672-2012)MOOG Medical Devices Group2012-05-30
Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly The Curlin A recall (Z-1401-2012)MOOG Medical Devices Group2012-04-13
Curlin 6000 CMS Ambulatory Infusion Pump Provides a means for the volumetric delivery of f recall (Z-1867-2011)Zevex International, Inc.2011-04-05
Curlin 6000 IOD Ambulatory Infusion Pump Provides a means for the volumetric delivery of f recall (Z-1868-2011)Zevex International, Inc.2011-04-05
Curlin PainSmart Ambulatory Infusion Pump Provides a means for the volumetric delivery of recall (Z-1869-2011)Zevex International, Inc.2011-04-05
Curlin PainSmart IOD Ambulatory Infusion Pump Provides a means for the volumetric delivery recall (Z-1870-2011)Zevex International, Inc.2011-04-05
Curlin Infusion Administration Set, REF 340-4111, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1439-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4114, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1440-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4115, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1441-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4126, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1442-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4127, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1443-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4128, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1444-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4128-V, Sterile EO, Zevex, Inc., 4314 Zevex Pa recall (Z-1445-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4130, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1446-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4130-V, Sterile EO, Zevex, Inc., 4314 Zevex Pa recall (Z-1447-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4134, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1448-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4137, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1449-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4144, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1450-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4162, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1451-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4164, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1452-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4167, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1453-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4168, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1454-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4169, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1455-2011)Zevex International, Inc.2011-02-25
Curlin Infusion Administration Set, REF 340-4176, Sterile EO, Zevex, Inc., 4314 Zevex Park recall (Z-1456-2011)Zevex International, Inc.2011-02-25
***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4119, Sterile EO, Zevex, recall (Z-2807-2011)Zevex International, Inc.2011-02-25
***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4175, Sterile EO, Zevex, recall (Z-2808-2011)Zevex International, Inc.2011-02-25
***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, Zevex, recall (Z-2809-2011)Zevex International, Inc.2011-02-25
Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump, Model Number: 340-1001 recall (Z-1896-2008)Curlin Medical Llc2008-09-22
Model 4000 Plus Ambulatory Infusion Pump, Model Number: 350-1001 recall (Z-1897-2008)Curlin Medical Llc2008-09-22
Model 4000 CMS Ambulatory Infusion Pump, Model Number: 350-1101 recall (Z-1898-2008)Curlin Medical Llc2008-09-22
Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101 recall (Z-1899-2008)Curlin Medical Llc2008-09-22
PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301 recall (Z-1900-2008)Curlin Medical Llc2008-09-22
Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets. recall (Z-1129-2007)Curlin Medical Llc2007-08-07