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Data / Medical devices / United States / Salaera, LLC d.b.a Maxtec

Salaera, LLC d.b.a Maxtec: FDA-registered device maker in Salt Lake City, UT, United States, 27 510(k) clearances

Salaera, LLC d.b.a Maxtec is registered with the FDA (registration 1722070) in Salt Lake City, UT, United States. It lists 19 device types. The FDA files 27 510(k) clearances under its listings, the newest dated December 4, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Salaera, LLC d.b.a Maxtec
FDA registration number
1722070
FEI number
1000117260
Address
2305 S 1070 W, Salt Lake City, UT, United States, 84119
Owner or operator
Salaera, LLC d.b.a Maxtec (9042996)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
September 14, 2004
Registered through
2026
Brand names listed
03920A LOW FLOW AIR/OXYGEN MICROBLENDER, 2-in-1 and 3-in-1 Adapters, APA(TM) DAB (clean, non-sterile); APA(TM) DAB (sterile); APA(TM) Handle and APA(TM) Camera Module; APA(TM) MAC 3 Blade (, Air/Oxygen Straight and Coiled Hoses, Bird MicroBlender, Blend-Up Accessory Kit, Blender Buddy, BlenderBuddy2 and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Repackager or relabeleraccessdata.fda.gov
Flowmeter, Calibration, GasBXY1Manufactureraccessdata.fda.gov
Flowmeter, Tube, Thorpe, Back-Pressure CompensatedCAX1Manufactureraccessdata.fda.gov
Hood, Oxygen, InfantFOG1Manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Repackager or relabeleraccessdata.fda.gov
Mixer, Breathing Gases, Anesthesia InhalationBZR2Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)CAP2Manufacturer, Repackager or relabeleraccessdata.fda.gov
OximeterDQA2Repackager or relabeleraccessdata.fda.gov
Oximeter, EarDPZ2Repackager or relabeleraccessdata.fda.gov
Pad, Neonatal EyeFOK1Manufactureraccessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)BZK2Repackager or relabeleraccessdata.fda.gov
Stand, InfusionFOX1Manufactureraccessdata.fda.gov
System, Thermal RegulatingDWJ2Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeleraccessdata.fda.gov
Transducer, Gas FlowBXP1Repackager or relabeleraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Manufactureraccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 4, 2023K231895Maxtec MaxBlend2+pBZRSubstantially EquivalentMaxtec, LLCaccessdata.fda.gov
April 1, 2023K221734Maxtec MaxO2 ME+pCCLSubstantially EquivalentMaxtec, LLCaccessdata.fda.gov
February 9, 2018K172284NAPA LP-15 Airway Pressure MonitorCAPSubstantially EquivalentDrw Medical, LLCaccessdata.fda.gov
October 27, 2016K161718MaxBlend 2, MaxBlend LiteBZRSubstantially EquivalentMaxtec, LLCaccessdata.fda.gov
June 10, 2016K153659MaxO2MECCLSubstantially EquivalentMaxtec, LLCaccessdata.fda.gov
November 14, 2014K140078TECOTHERM NEO (T NEO)DWJSubstantially EquivalentInspiration Healthcare, Ltd.accessdata.fda.gov
May 2, 2014K133064MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31DQASubstantially EquivalentEnvitec-Wismar GmbHaccessdata.fda.gov
January 23, 2013K122290ENVITEC MYSIGN O OXYGEN MEASURING DEVICECCLSubstantially EquivalentEnvitec-Wismar GmbHaccessdata.fda.gov
March 1, 2012K113232MAXMIXING BLOCKBZRSubstantially EquivalentMaxtec, Inc.accessdata.fda.gov
January 27, 2012K112804FINGERTIP PULSE OXIMETERDQASubstantially EquivalentGuangdong Biolight Meditech Co., Ltd.accessdata.fda.gov
December 14, 2011K112402ULTRAMAXO2 OXYGEN ANALYERCCLSubstantially EquivalentMaxtec, LLCaccessdata.fda.gov
September 8, 2010K101694HANDHELD PULSE OXIMETER MODEL M800DQASubstantially EquivalentGuangdong Biolight Meditech Co., Ltd.accessdata.fda.gov
September 12, 2008K081712FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700DQASubstantially EquivalentGuangdong Biolight Meditech Co., Ltd.accessdata.fda.gov
May 31, 2007K062149SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIESDQASubstantially EquivalentInternational Business Strategiesaccessdata.fda.gov
February 22, 2007K063488MAXO2 CUCCLSubstantially EquivalentMaxtec, Inc.accessdata.fda.gov
January 10, 2006K053232PRECISION BLENDERBZRSubstantially EquivalentPrecision Medical, Inc.accessdata.fda.gov
September 7, 2005K051279CALDYNE, INC. EXHALOMETER EX100, MODEL EX100BZKSubstantially EquivalentCaldyne, Inc.accessdata.fda.gov
June 9, 2004K040484MAXO2+, MODEL A AND AECCLSubstantially EquivalentMaxtec, Inc.accessdata.fda.gov
December 8, 2000K002951MAGELLAN VENTILATORCBKSubstantially EquivalentOceanic Medical Products, Inc.accessdata.fda.gov
August 31, 2000K000700SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITORCCLSubstantially EquivalentSensidyne, Inc.accessdata.fda.gov
May 7, 1998K973646BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZERBZRSubstantially EquivalentBird Products Corp.accessdata.fda.gov
March 30, 1998K972992CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORSCCLSubstantially EquivalentCeramatec, Inc.accessdata.fda.gov
March 4, 1998K973282HANDI OXYGEN ANALYZERCCLSubstantially EquivalentCeramatec, Inc.accessdata.fda.gov
November 25, 1996K963415VENTREX OXYGEN SENSORCCLSubstantially EquivalentVentrex, LLCaccessdata.fda.gov
October 8, 1991K911962BIRD SENTRY AIR/OXYGEN MICROBLENDERBZRSubstantially EquivalentBird Products Corp.accessdata.fda.gov
June 18, 1991K911344CERION HAND HELD OXYGEN ANALYZERCCLSubstantially EquivalentCeramatec, Inc.accessdata.fda.gov
November 16, 1988K883038P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDERBZRSubstantially EquivalentBird Products Corp.accessdata.fda.gov

Compare with other makers

Updated December 4, 2023. 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.