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Caf Medical Solutions Inc: FDA-registered device maker in Hockley, TX, United States, 3 510(k) clearances

Name: Caf Medical Solutions Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Caf Medical Solutions Inc is registered with the FDA (registration 3021559257) in Hockley, TX, United States. It lists 32 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 10, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3021559257
Address: 17539 Roberts Road, Hockley, TX, United States, 77447
Owner or operator: CAF Medical Solutions Inc (10084159)
Roles: Manufacturer, Manufacturer for export
First device listed: February 25, 2022
Registered through: 2026
Brand names listed: BED, HYDRAULIC, ADJUSTABLE HOSPITAL, Electrocardiograph, L-IW B Infant Radiant Warmer, L-IW Infant Radiant Warmer, L-NI6 Neonatal incubator, L-NI8 Neonatal incubator, L3 Defibrillator monitor, L5 Defibrillator Monitor and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	2	Manufacturer	accessdata.fda.gov
Automated External Defibrillators (Non-Wearable)	MKJ	3	Manufacturer for export	accessdata.fda.gov
Bed, Ac-Powered Adjustable Hospital	FNL	2	Manufacturer	accessdata.fda.gov
Bed, Hydraulic, Adjustable Hospital	FNK	1	Manufacturer	accessdata.fda.gov
Cabinet, Table And Tray, Anesthesia	BRY	1	Manufacturer	accessdata.fda.gov
Clip, Vena-Cava	DST	2	Manufacturer	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Manufacturer	accessdata.fda.gov
Electrocardiograph	DPS	2	Manufacturer	accessdata.fda.gov
Gas-Machine, Anesthesia	BSZ	2	Manufacturer for export	accessdata.fda.gov
Incubator, Neonatal	FMZ	2	Manufacturer for export	accessdata.fda.gov
Lamp, Operating-Room	FQP	2	Manufacturer	accessdata.fda.gov
Light, Surgical, Floor Standing	FSS	2	Manufacturer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Manufacturer	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Manufacturer	accessdata.fda.gov
Monitor, St Segment With Alarm	MLD	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Manufacturer	accessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)	BZK	2	Manufacturer	accessdata.fda.gov
Stretcher, Wheeled	FPO	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer	accessdata.fda.gov
Table, Operating-Room, Electrical	GDC	1	Manufacturer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Manufacturer	accessdata.fda.gov
Warmer, Infant Radiant	FMT	2	Manufacturer for export	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
August 10, 2022	K221879	Patient Monitor, models LM-8, LM-10, LM-12 and LM-15	MHX	Substantially Equivalent	Caf Medical Solutions, Inc.	accessdata.fda.gov
August 1, 2022	K221616	Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17	MHX	Substantially Equivalent	Caf Medical Solutions, Inc.	accessdata.fda.gov
March 25, 2022	K220362	LE-12CH	DPS	Substantially Equivalent	Caf Medical Solutions, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 10, 2022. 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.