Company ยท US
Precision Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2018. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 5 |
| BTI | Compressor, Air, Portable | 3 |
| BYJ | Unit, Liquid-Oxygen, Portable | 3 |
| CAN | Regulator, Pressure, Gas Cylinder | 3 |
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | 3 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 |
| BXY | Flowmeter, Calibration, Gas | 2 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 |
| CAW | Generator, Oxygen, Portable | 2 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 2 |
| KDP | Regulator, Vacuum | 2 |
| NFB | Conserver, Oxygen | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
| KDQ | Bottle, Collection, Vacuum | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 2, 2018 | K173807 | Accu O2 Oxygen Analyzer Precision Medical, Inc. | CCL |
| Apr 25, 2014 | K140179 | EASY GO VAC Precision Medical, Inc. | BTA |
| Jul 1, 2011 | K103563 | PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 Precision Medical, Inc. | CAW |
| Apr 21, 2011 | K103324 | PRECISION LIQUID OXYGEN SYSTEM Precision Medical, Inc. | BYJ |
| Aug 13, 2009 | K090781 | HELIO2 BLENDER Precision Medical, Inc. | BZR |
| Oct 27, 2008 | K072348 | PRECISION OXYGEN CONCENTRATOR Precision Medical, Inc. | CAW |
| Feb 27, 2007 | K063096 | PRECISION OXYGEN MONITOR Precision Medical, Inc. | CCL |
| Jan 10, 2006 | K053232 | PRECISION BLENDER Precision Medical, Inc. | BZR |
| Dec 9, 2005 | K051691 | MINIMATE COMPRESSOR Precision Medical, Inc. | BTI |
| Oct 4, 2004 | K041122 | PRECISION LIQUID OXYGEN SYSTEM Precision Medical, Inc. | BYJ |
| Aug 25, 2003 | K032018 | EASY PULSE II OXYGEN CONSERVER Precision Medical, Inc. | NFB |
| Mar 20, 2001 | K001412 | PM 1800 CONSERVING DEVICE Precision Medical, Inc. | NFB |
| Apr 1, 1998 | K971749 | EASYGO ASPIRATOR Precision Medical, Inc. | BTA |
| Dec 22, 1994 | K944479 | PM3300 INTERMITTENT VACUUM Precision Medical, Inc. | KDP |
| Dec 12, 1994 | K941818 | PM9000 VAC TRAP Precision Medical, Inc. | KDQ |
| Dec 6, 1994 | K942350 | CAREPAK Precision Medical, Inc. | CAF |
| Oct 28, 1994 | K930509 | PM PUMP COMPRESSOR Precision Medical, Inc. | BTI |
| Oct 25, 1993 | K932006 | 1500 SERIES REGULATOR Precision Medical, Inc. | CAN |
| Oct 7, 1993 | K932494 | PM PUMP ASPIRATOR Precision Medical, Inc. | BTA |
| Mar 4, 1993 | K922817 | PM3000 & PM3100 VACUUM REGULATOR Precision Medical, Inc. | KDP |
| Jan 14, 1993 | K923324 | PRECISION MIST COMPRESSOR Precision Medical, Inc. | CAF |
| Aug 14, 1990 | K902970 | PRECISION MEDICAL DISPOSABLE HUMIDIFIER Precision Medical, Inc. | BTT |
| Aug 14, 1990 | K901831 | PRECISION MEDICAL OXYGEN REGULATOR Precision Medical, Inc. | CAN |
| Jul 30, 1990 | K902762 | PM14 SOFT AIR COMPRESSOR Precision Medical, Inc. | BTI |
| Jul 23, 1990 | K902917 | PRECISION MEDICAL ELIMINATOR Precision Medical, Inc. | BXY |
| Jul 23, 1990 | K902916 | PRECISION MEDICAL NEB BLOCK Precision Medical, Inc. | BXY |
| Oct 29, 1985 | K854067 | SELECT FLOWMETER Precision Medical, Inc. | CAX |
| Apr 25, 1985 | K850559 | PRESSURE RELIEF ADAPTOR Precision Medical, Inc. | CAX |
| Apr 17, 1985 | K850560 | FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE Precision Medical, Inc. | CAX |
| Sep 27, 1984 | K843223 | FLOW CONTROLLER Precision Medical, Inc. | BTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2015 | Precision Medical, Inc. Easy 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. Terminated |
CAN | K901831 |
| May 9, 2010 | Precision Medical, Inc. PM1000 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 Terminated |
BTM | K843223 |
| Nov 4, 2006 | Precision Medical, Inc. Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number 2201, Precision Medical, Inc., Northampton, PA 18067 Terminated |
BYJ | K041122 |
| Dec 15, 2004 | Precision Medical, Inc. Easy Go Vac Aspirator, Model PM65HG. Portable suction unit Terminated |
BTA | K971749 |
| Dec 15, 2004 | Precision Medical, Inc. Easy Go Vac Aspirator, Model PM65. Portable suction unit Terminated |
BTA | K971749 |