510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Precision Medical, Inc.

Northampton, PA, US

PRECISION MEDICAL, INC. appears in FDA device records in Northampton, PA. FDA records list 30 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
30
PMA records
0
Recall records
5
Registered establishments
1

510(k) clearance history

FDA records hold 30 510(k) clearances for Precision Medical, Inc. between 1984 and 2018. The busiest year on record is 1990, with 5. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Precision Medical, Inc., by decision year
YearClearances
19841
19853
19905
19934
19944
19981
20011
20031
20041
20051
20061
20071
20081
20091
20112
20141
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K173807Accu O2 Oxygen AnalyzerCCLSubstantially Equivalent
K140179EASY GO VACBTASubstantially Equivalent
K103563PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150CAWSubstantially Equivalent
K103324PRECISION LIQUID OXYGEN SYSTEMBYJSubstantially Equivalent
K090781HELIO2 BLENDERBZRSubstantially Equivalent
K072348PRECISION OXYGEN CONCENTRATORCAWSubstantially Equivalent
K063096PRECISION OXYGEN MONITORCCLSubstantially Equivalent
K053232PRECISION BLENDERBZRSubstantially Equivalent
K051691MINIMATE COMPRESSORBTISubstantially Equivalent
K041122PRECISION LIQUID OXYGEN SYSTEMBYJSubstantially Equivalent
K032018EASY PULSE II OXYGEN CONSERVERNFBSubstantially Equivalent
K001412PM 1800 CONSERVING DEVICENFBSubstantially Equivalent
K971749EASYGO ASPIRATORBTASubstantially Equivalent
K944479PM3300 INTERMITTENT VACUUMKDPSubstantially Equivalent
K941818PM9000 VAC TRAPKDQSubstantially Equivalent
K942350CAREPAKCAFSubstantially Equivalent
K930509PM PUMP COMPRESSORBTISubstantially Equivalent
K9320061500 SERIES REGULATORCANSubstantially Equivalent
K932494PM PUMP ASPIRATORBTASubstantially Equivalent
K922817PM3000 & PM3100 VACUUM REGULATORKDPSubstantially Equivalent
K923324PRECISION MIST COMPRESSORCAFSubstantially Equivalent
K902970PRECISION MEDICAL DISPOSABLE HUMIDIFIERBTTSubstantially Equivalent
K901831PRECISION MEDICAL OXYGEN REGULATORCANSubstantially Equivalent
K902762PM14 SOFT AIR COMPRESSORBTISubstantially Equivalent
K902917PRECISION MEDICAL ELIMINATORBXYSubstantially Equivalent
K902916PRECISION MEDICAL NEB BLOCKBXYSubstantially Equivalent
K854067SELECT FLOWMETERCAXSubstantially Equivalent
K850559PRESSURE RELIEF ADAPTORCAXSubstantially Equivalent
K850560FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBECAXSubstantially Equivalent
K843223FLOW CONTROLLERBTMSubstantially Equivalent

Registered establishments

FDA registered establishments for Precision Medical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
25231482523148PRECISION MEDICAL, INC.300 HELD DR., NORTHAMPTON, PA 18067 US2026and 3 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0272-2016Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For the 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25).Class IITerminated
Z-1561-2010PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of the three outlets it provides.The on/off outlet is mislabeled so that when a user/operator turns selector to "on", it actually may be turned "off"Terminated
Z-0153-2007Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number 2201, Precision Medical, Inc., Northampton, PA 18067Component assembly; The fill chuck is not assembled properly which may allow the device to come apart over time releasing its contents.Terminated
Z-0308-05Easy Go Vac Aspirator, Model PM65HG. Portable suction unitBattery charger can be overcharged and overheatTerminated
Z-0307-05Easy Go Vac Aspirator, Model PM65. Portable suction unitBattery charger can be overcharged and overheatTerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain