Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1722070

FEI Number

1000117260

Entity Name

Salaera, LLC d.b.a Maxtec

City/State/Country

Salt Lake City, UT, US

Establishment Address

2305 S 1070 W, Salt Lake City, UT 84119, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Salaera, LLC d.b.a Maxtec (Owner Number: 9042996)

Owner / Operator Contact Address

2305 South 1070 West, Salt Lake City, UT 84119, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K040484

PMA Number

N/A

All Registered Proprietary Names

MaxFlo2 Mini MaxFLO2 High and Low Flow Mixing Blocks / MaxMixing Block Air/Oxygen Straight and Coiled Hoses 2-in-1 and 3-in-1 Adapters Blender Buddy Blend-Up Accessory Kit BlenderBuddy2 M800 Pulse Oximeter TEC Oxygen Sensors APA(TM) DAB (clean, non-sterile); APA(TM) DAB (sterile); APA(TM) Handle and APA(TM) Camera Module; APA(TM) MAC 3 Blade ( NAPA LP 15 MaxO2 Vent M70A and M70C Pulse Oximeter Exhalometer MaxO2ME SUPERDOME Stand Alone Acrylic Flowmeter MicroMax - Low and High Flow Microblenders Mysign S 03920A LOW FLOW AIR/OXYGEN MICROBLENDER Bird MicroBlender MaxBlend2+p Max-250MKT Max-250 + Max-250TM Max-250TL Max-250K Max-250MST Max-250E Max-250MS Max-250 XPCB Max-250A Max-250TE Max-250SLE Max-250TA Maxtec Oxygen Sensors Max-250MK MAX-250TEL MaxBlend 2 Sentry 2 Stand, SmartStack Stand, SmartStack and Universal Tray Bird MicroBlender UltraMaxO2 Oxygen Analyzer FloCap CO2 Indicator Max02

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2012-03-05
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2010-01-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-06-26
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2010-03-22
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2017-12-14
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2018-12-05
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2014-12-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-06-26
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2021-12-20
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2014-01-27
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2014-01-27
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2016-06-15
FOG	Hood, Oxygen, Infant	Anesthesiology	Class 1	868.5700	2004-09-14
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	2017-07-19
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2012-03-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-12-05
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2018-12-05
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2025-03-17
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2023-12-19
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2023-12-19
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2023-12-19
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2007-11-30
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2016-11-17
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2016-11-17
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2010-01-04
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2018-12-05
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2012-01-16
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2014-03-28
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2007-11-30

Official Correspondent

Anvitha Anand Rao

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Salaera, LLC d.b.a Maxtec

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1722070. Last updated year: 2026. Please use registration number 1722070 when referencing this establishment in official correspondence.