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Data / Medical devices / United States / Mercury Medical Enterprises, LLC

Mercury Medical Enterprises, LLC: FDA-registered device maker in Clearwater, FL, United States, 21 510(k) clearances

Mercury Medical Enterprises, LLC is registered with the FDA (registration 1024404) in Clearwater, FL, United States. It lists 21 device types. The FDA files 21 510(k) clearances under its listings, the newest dated March 3, 2023. 3 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Mercury Medical Enterprises, LLC
FDA registration number
1024404
Address
11300 49th St N, Clearwater, FL, United States, 33762
Owner or operator
Mercury Medical Enterprises, LLC (1024404)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
December 30, 1977
Registered through
2026
Brand names listed
AIRWAY PRESSURE MANOMETER, AIRWAYS (MULTIPLE), ANESTHESIA CIRCUIT (MAPLESON), CLEAR ANATOMICAL FACE MASK, CPR BAG (MUTIPLE), CPR BAG (REUSABLE), DISPOSEAL, EXHALATION FILTER (CPR) and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, Oropharyngeal, AnesthesiologyCAE1Manufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Manufactureraccessdata.fda.gov
Attachment, Breathing, Positive End Expiratory PressureBYE2Manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Manufactureraccessdata.fda.gov
Clip, NoseBXJ1Repackager or relabeleraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Manufactureraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Manufactureraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Manufactureraccessdata.fda.gov
Meter, Airway Pressure (Inspiratory Force)BXR2Manufactureraccessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)CAP2Manufactureraccessdata.fda.gov
Mouthpiece, BreathingBYP1Manufactureraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Manufactureraccessdata.fda.gov
Percussor, Powered-ElectricBYI2Manufactureraccessdata.fda.gov
Protector, DentalBRW1Manufactureraccessdata.fda.gov
Resuscitator, Manual, Non Self-InflatingNHK2Manufactureraccessdata.fda.gov
Spirometer, Therapeutic (Incentive)BWF2Manufactureraccessdata.fda.gov
Support, Patient PositionCCX1Manufactureraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Contract manufacturer, Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Manufactureraccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Manufactureraccessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)BTL2Manufactureraccessdata.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
March 3, 2023K222880Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)KNTSubstantially EquivalentEndolumik, Inc.accessdata.fda.gov
March 17, 2017K161250OC-FLEX Flexible IntraOral CannulaCCKSubstantially EquivalentVenture Therapeutics, Inc.accessdata.fda.gov
October 17, 2014K142096T-PIECE RESUSCITATORBTLSubstantially EquivalentMercury Medicalaccessdata.fda.gov
November 22, 2013K121587BREATH SHAKEBYISubstantially EquivalentCheen Houng Ent. Co. , Ltd.accessdata.fda.gov
April 6, 2010K093913MERCURY MEDICAL T-PIECE RESUSCITATORBTLSubstantially EquivalentMercury Medical, Inc.accessdata.fda.gov
August 20, 2009K090710MERCURY CPAPBYESubstantially EquivalentMercury Medicalaccessdata.fda.gov
March 5, 2009K081266MERCURY MEDICAL PEEP VALVEBYESubstantially EquivalentMercury Enterprizes Dba Mercury Medicalaccessdata.fda.gov
February 23, 2009K083056NEO-STAT CO2 <KGCCKSubstantially EquivalentMercury Medicalaccessdata.fda.gov
February 3, 2004K032593MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETERBXRSubstantially EquivalentMercury Medicalaccessdata.fda.gov
July 30, 2003K031411MINI STATCO2 CO2 DETECTOR, MODEL 10-55371CCKSubstantially EquivalentMercury Medicalaccessdata.fda.gov
January 28, 2003K023579GAS SAMPLING LINESCCKSubstantially EquivalentPromedic, Inc.accessdata.fda.gov
November 4, 2002K021576MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370CCKSubstantially EquivalentMercury Medicalaccessdata.fda.gov
November 3, 2000K001714MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149NHKSubstantially EquivalentMercury Medicalaccessdata.fda.gov
November 12, 1999K993558EZFLOW MAX, MODEL 1007CAFSubstantially EquivalentPiper Medical Productsaccessdata.fda.gov
April 26, 1999K990384EZFLOW CONTINUOUS NEBULIZER,MODEL 1005CAFSubstantially EquivalentPiper Medical Productsaccessdata.fda.gov
October 31, 1997K970756MERCURY MEDICAL REUSABLE CPR BAGBTMSubstantially EquivalentMercury Medicalaccessdata.fda.gov
October 3, 1996K954490MERCURY MEDICAL CPR BAG EXHALATION FILTERCAHSubstantially EquivalentMercury Medicalaccessdata.fda.gov
April 25, 1996K954486MERCURY AIRWAY PRESSURE MANOMETERCAPSubstantially EquivalentMercury Medicalaccessdata.fda.gov
January 30, 1996K954866MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIRBTMSubstantially EquivalentMercury Medicalaccessdata.fda.gov
September 19, 1994K942919MERCURY EXPIRATORY RESISTANCE EXERCISERBWFSubstantially EquivalentMercury Ent., Inc. D/B/A Mercury Medicalaccessdata.fda.gov
May 20, 1991K911622CPR BAGBTMSubstantially EquivalentMerced Medical, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
December 10, 202495967Class IOngoingNeo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.accessdata.fda.gov
August 30, 202495303Class IOngoingNeo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.accessdata.fda.gov
October 22, 201572540Class IITerminatedMercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tuIncorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.accessdata.fda.gov

Compare with other makers

Updated January 10, 2025. 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.