Data / Medical devices / United States / Zevex, Inc.
Zevex, Inc.: FDA-registered device maker in Salt Lake City, UT, United States, 4 510(k) clearances
Zevex, Inc. is registered with the FDA (registration 1722139) in Salt Lake City, UT, United States. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 17, 2024. 12 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1722139
- FEI number
- 1000117172
- Address
- 4314 Zevex Park LN., Salt Lake City, UT, United States, 84123
- Owner or operator
- MOOG, INC. (9086921)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- August 6, 1999
- Registered through
- 2026
- Brand names listed
- Abbott FreeGo Feeding pump, CUSA Clarity Handpiece, Curlin 8000 IV Infusion Pump, ENFit Enteral Administration Sets, Fragmentation; Stellaris, NGPC Frag Handpiece; Stellaris PC Frag Handpiece, Pump, Infusion, SOVEREIGN CATARACT EXTRACTION SYSTEM and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Irrigation, Ocular Surgery | KYG | 1 | Contract manufacturer | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Ultrasonic Surgical | LFL | U | Contract manufacturer | accessdata.fda.gov |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | 2 | Contract manufacturer | accessdata.fda.gov |
| Neurosurgical Ultrasonic Instruments | LBK | U | Contract manufacturer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion, Enteral | LZH | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Phacofragmentation | HQC | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 17, 2024 | K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets | FRN | Substantially Equivalent | Zevex, Inc. | accessdata.fda.gov |
| January 8, 2015 | K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set | PIF | Substantially Equivalent | Zevex, Inc. | accessdata.fda.gov |
| July 9, 2003 | K031199 | ENTERALITE INFINITY ENTERAL FEEDING PUMP | LZH | Substantially Equivalent | Zevex Intl., Inc. | accessdata.fda.gov |
| December 4, 1998 | K981816 | CUE AMBULATORY VOLUMETRIC INFUSION PUMP | FRN | Substantially Equivalent | Becton Dickinson Curlin, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 27, 2019 | 82864 | Class II | Terminated | MOOG Curlin Infusion Administration Set, REF, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set to be used with the Moog Curlin In | Administration sets leaked at the filter. | accessdata.fda.gov |
| November 10, 2017 | 78573 | Class II | Terminated | MOOG Curlin Infusion Administration Set, Ref, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administra | Particulate found on the Curlin spike. | accessdata.fda.gov |
| December 23, 2015 | 72923 | Class II | Terminated | Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD | 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 of tolerance and may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed. | accessdata.fda.gov |
| November 20, 2015 | 72682 | Class II | Terminated | Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set | Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector. | accessdata.fda.gov |
| November 8, 2012 | 63660 | Class II | Terminated | EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery o | MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely. | accessdata.fda.gov |
| October 12, 2012 | 63485 | Class II | Terminated | Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications. | The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line. | accessdata.fda.gov |
| September 26, 2012 | 63359 | Class II | Terminated | This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets a | 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 of Curlin Administration Sets used with Curlin Ambulatory Infusion Pumps. The lots associated with this recall were inadvertently omitted from the original rec | accessdata.fda.gov |
| May 18, 2012 | 61895 | Not yet classified | Terminated | Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly, product code:, Method of Sterilization using Ethylene Oxide. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tu | 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 backwards from what was intended. | accessdata.fda.gov |
| March 20, 2012 | 61446 | Not yet classified | Terminated | Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volume | 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. | accessdata.fda.gov |
| February 28, 2011 | 57939 | Not yet classified | Terminated | Curlin 6000 CMS Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. | Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed. | accessdata.fda.gov |
| January 24, 2011 | 57829 | Not yet classified | Terminated | Curlin Infusion Administration Set, REF, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accesso | Defect in tubing may trigger false Air-In-Line warning. | accessdata.fda.gov |
| December 18, 2008 | 50687 | Not yet classified | Terminated | EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123. A rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at s | Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- All makers of Unit, Phacofragmentation
- All makers of Pump, Infusion
- All makers of Set, Administration, Intravascular
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
- All makers of Neurosurgical Ultrasonic Instruments
Updated May 17, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.