Data / Medical devices / United States / Tribalco

Tribalco: FDA-registered device maker in Tampa, FL, United States, 13 510(k) clearances

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

Tribalco is registered with the FDA (registration 3010317211) in Tampa, FL, United States. It lists 18 device types. The FDA files 13 510(k) clearances under its listings, the newest dated May 31, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010317211
Address: 1802 Grant St Ste 300, Tampa, FL, United States, 33605
Owner or operator: Tribalco (10044850)
Roles: Repackager or relabeler
First device listed: August 8, 2013
Registered through: 2026
Brand names listed: C MAC 8403 Video Laryngoscope, CHAMBERLITE; GAMOW; OASIS; RESPIRO; SOLACE; VITAERIS, EMMA Phasein, Generator, Geratherm Mini Rescue II R130, MEQU Warmer System, Model 9550, Onyx II; Model 9570; Model 9571; Model 9590; Onyx Vantage, Monitor and more

Devices it lists

Device	Product code	Class	Role	Source
Aid, Cardiopulmonary Resuscitation	LIX	2	Repackager or relabeler	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Repackager or relabeler	accessdata.fda.gov
Automated External Defibrillators (Non-Wearable)	MKJ	3	Repackager or relabeler	accessdata.fda.gov
Chamber, Hyperbaric	CBF	2	Repackager or relabeler	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Repackager or relabeler	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Repackager or relabeler	accessdata.fda.gov
Dc-Defibrillator, Low-Energy, (Including Paddles)	LDD	2	Repackager or relabeler	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Repackager or relabeler	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Repackager or relabeler	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	DRO	2	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov
System, Thermal Regulating	DWJ	2	Repackager or relabeler	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Repackager or relabeler	accessdata.fda.gov
Warmer, Blood, Non-Electromagnetic Radiation	BSB	2	Repackager or relabeler	accessdata.fda.gov
Warmer, Thermal, Infusion Fluid	LGZ	2	Repackager or relabeler	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 31, 2024	K232107	°M Warmer System	LGZ	Substantially Equivalent	Mequ A/S	accessdata.fda.gov
January 29, 2021	K202970	Ventway Sparrow	CBK	Substantially Equivalent	Inovytech Medical Solutions , Ltd.	accessdata.fda.gov
June 5, 2013	K130773	TEMPUS PRO PATIENT MONITOR	MWI	Substantially Equivalent	Remote Diagnostic Technologies , Ltd.	accessdata.fda.gov
September 19, 2012	K120657	MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS	DQA	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
April 25, 2012	K112761	ZOLL PROPAQ MD	MKJ	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters	accessdata.fda.gov
September 20, 2010	K093694	GERATHERM UNIQUERESC	DWJ	Substantially Equivalent	Geratherm Medical AG	accessdata.fda.gov
October 20, 2009	K083163	OMNI 2 OXYGEN SYSTEM	CAW	Substantially Equivalent	Sequal Technologies, Inc.	accessdata.fda.gov
March 26, 2009	K090508	THE BELMONT BUDDY LITE FLUID WARMER	BSB	Substantially Equivalent	Belmont Instrument Corp.	accessdata.fda.gov
December 28, 2007	K072813	EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)	CCK	Substantially Equivalent	Phasein AB	accessdata.fda.gov
June 22, 2007	K071025	ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO	MKJ	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters	accessdata.fda.gov
June 5, 2007	K070878	DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300	FLL	Substantially Equivalent	Rg Medical Diagnostics	accessdata.fda.gov
June 1, 2005	K051107	ONYX II FINGER PULSE OXIMETER, MODEL 9550	DQA	Substantially Equivalent	Nonin Medical, Inc.	accessdata.fda.gov
August 2, 2000	K001409	GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER	CBF	Substantially Equivalent	Hyperbaric Technologies, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 31, 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.