Precision Medical, Inc.
Medical device manufacturer in Northampton, PA.
30510(k) clearances
0PMA approvals
3recalls
Device types
- CAX Flowmeter, Tube, Thorpe, Back-Pressure… 3
- BTI Compressor, Air, Portable 3
- BTA Pump, Portable, Aspiration (Manual Or… 3
- BXY Flowmeter, Calibration, Gas 2
- CAN Regulator, Pressure, Gas Cylinder 2
- CAF Nebulizer (Direct Patient Interface) 2
- KDP Regulator, Vacuum 2
- NFB Conserver, Oxygen 2
- BYJ Unit, Liquid-Oxygen, Portable 2
- BZR Mixer, Breathing Gases, Anesthesia Inhalation 2
- CCL Analyzer, Gas, Oxygen, Gaseous-Phase 2
- CAW Generator, Oxygen, Portable 2
- BTM Ventilator, Emergency, Manual (Resuscitator) 1
- BTT Humidifier, Respiratory Gas, (Direct… 1
- KDQ Bottle, Collection, Vacuum 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | 05/02/2018SE |
| K140179 | Easy Go VacBTA · Special | 04/25/2014SE |
| K103563 | Precision Portable Oxygen Concentration Model 4150CAW · Traditional | 07/01/2011SE |
| K103324 | Precision Liquid Oxygen SystemBYJ · Traditional | 04/21/2011SE |
| K090781 | HELIO2 BlenderBZR · Traditional | 08/13/2009SE |
| K072348 | Precision Oxygen ConcentratorCAW · Abbreviated | 10/27/2008SE |
| K063096 | Precision Oxygen MonitorCCL · Abbreviated | 02/27/2007SE |
| K053232 | Precision BlenderBZR · Traditional | 01/10/2006SE |
| K051691 | Minimate CompressorBTI · Traditional | 12/09/2005SE |
| K041122 | Precision Liquid Oxygen SystemBYJ · Traditional | 10/04/2004SE |
| K032018 | Easy Pulse II Oxygen ConserverNFB · Traditional | 08/25/2003SE |
| K001412 | PM 1800 Conserving DeviceNFB · Abbreviated | 03/20/2001SE |
| K971749 | Easygo AspiratorBTA · Traditional | 04/01/1998SE |
| K944479 | PM3300 Intermittent VacuumKDP · Traditional | 12/22/1994SE |
| K941818 | PM9000 Vac TrapKDQ · Traditional | 12/12/1994SE |
| K942350 | CarepakCAF · Traditional | 12/06/1994SE |
| K930509 | PM Pump CompressorBTI · Traditional | 10/28/1994SE |
| K932006 | 1500 Series RegulatorCAN · Traditional | 10/25/1993SE |
| K932494 | PM Pump AspiratorBTA · Traditional | 10/07/1993SE |
| K922817 | PM3000 & PM3100 Vacuum RegulatorKDP · Traditional | 03/04/1993SE |
| K923324 | Precision Mist CompressorCAF · Traditional | 01/14/1993SE |
| K902970 | Precision Medical Disposable HumidifierBTT · Traditional | 08/14/1990SE |
| K901831 | Precision Medical Oxygen RegulatorCAN · Traditional | 08/14/1990SE |
| K902762 | PM14 Soft Air CompressorBTI · Traditional | 07/30/1990SE |
| K902917 | Precision Medical EliminatorBXY · Traditional | 07/23/1990SE |
| K902916 | Precision Medical Neb BlockBXY · Traditional | 07/23/1990SE |
| K854067 | Select FlowmeterCAX · Traditional | 10/29/1985SE |
| K850559 | Pressure Relief AdaptorCAX · Traditional | 04/25/1985SE |
| K850560 | Flowmeter, Backpressure Compensated, Thorpe TubeCAX · Traditional | 04/17/1985SE |
| K843223 | Flow ControllerBTM · Traditional | 09/27/1984SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0272-2016 Class II | Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15…These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator… | 10/08/2015Terminated |
| Z-1561-2010 | PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The…The on/off outlet is mislabeled so that when a user/operator turns selector to "on", it actually may be… | 03/05/2010Terminated |
| Z-0153-2007 | Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series…Component assembly; The fill chuck is not assembled properly which may allow the device to come apart over… | 10/04/2006Terminated |