Company ยท US
Allied Healthcare Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2014. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 9 |
| ECX | Cylinder, Compressed Gas, And Valve | 8 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 4 |
| CBK | Ventilator, Continuous, Facility Use | 2 |
| CBL | Absorbent, Carbon-Dioxide | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
| BYK | Tent, Oxygen, Electrically Powered | 1 |
| BZG | Spirometer, Diagnostic | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| CAW | Generator, Oxygen, Portable | 1 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| DOP | Mass Spectrometer, Clinical Use | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 9, 2014 | K131098 | EMERGENCY PORTABLE VENTILATOR Allied Healthcare Products, Inc. | BTL |
| Apr 2, 2014 | K132021 | AHP 300, EMERGENCY PORTABLE VENTILATOR Allied Healthcare Products, Inc. | BTL |
| May 20, 2009 | K090356 | EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 Allied Healthcare Products, Inc. | BTL |
| May 18, 2009 | K083507 | BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS Allied Healthcare Products, Inc. | BTL |
| May 14, 2009 | K083385 | MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B Allied Healthcare Products, Inc. | BTL |
| Aug 15, 2008 | K080063 | MASS CASUALTY VENTILATOR, MODEL MCV100 Allied Healthcare Products, Inc. | BTL |
| Mar 6, 2008 | K072214 | PORTABLE VENTILATOR, MODEL EPV-100 Allied Healthcare Products, Inc. | BTL |
| Jan 31, 2008 | K073171 | RESUSCITATION TIMER, MODEL L770-CPR Allied Healthcare Products, Inc. | BTM |
| Jul 13, 2007 | K070636 | AUTOVENT 4000 WITH CPAP Allied Healthcare Products, Inc. | BTL |
| May 3, 2007 | K070120 | AUTOVENT MODEL 4000 Allied Healthcare Products, Inc. | BTL |
| Oct 18, 2006 | K062080 | RESUSCITATION TIMER, MODEL L770-CPR Allied Healthcare Products, Inc. | BTM |
| Sep 15, 2005 | K051260 | SCHUCO MIST AND SCHUCO DELUXE MIST Allied Healthcare Products, Inc. | CAF |
| Oct 1, 2002 | K014071 | PMX DISPOSABLE BAG MASK RESUSCITATOR Allied Healthcare Products, Inc. | BTM |
| Jan 29, 1998 | K973106 | GOLEMB DISPOSABLE BAG MASK RESUSCITATOR Allied Healthcare Products, Inc. | BTM |
| Nov 6, 1997 | K972203 | BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT Allied Healthcare Products, Inc. | CBK |
| Aug 6, 1996 | K955865 | BEAR CUB INFANT PRESSURE VENTILATOR Allied Healthcare Products, Inc. | CBK |
| Mar 1, 1995 | K941547 | CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT Allied Healthcare Products, Inc. | BYK |
| Feb 10, 1994 | K932936 | L.A.P. II SPRIOMETRY SYSTEM Allied Healthcare Products, Inc. | BZG |
| Mar 19, 1993 | K924100 | OXYGEN CONCENTRATOR Allied Healthcare Products, Inc. | CAW |
| Sep 21, 1982 | K822614 | BLOOD PRESSURE MONITORING DEVICES Allied Healthcare Products, Inc. | DXN |
| May 27, 1981 | K811260 | BARALYME CO2 ABSORBENT Allied Healthcare Products, Inc. | CBL |
| Apr 23, 1981 | K810939 | NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI. Allied Healthcare Products, Inc. | BTT |
| Apr 23, 1981 | K810938 | MASS SPECTROMETER-MEDSPECT II Allied Healthcare Products, Inc. | DOP |
| Apr 14, 1981 | K810927 | RESPIRATORY INTENSIVE CARE SYSTEM (RICS) Allied Healthcare Products, Inc. | CCK |
| Mar 24, 1981 | K810585 | SARA Allied Healthcare Products, Inc. | CBS |
| Mar 13, 1981 | K810490 | GOMCO SUCTION PUMP CABINET CHANGE Allied Healthcare Products, Inc. | BTA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2011 | Allied Healthcare Products Inc Allied Healthcare Products Inc. CarbO2Lime Carbon Dioxide Absorbent Granules for Canister Refill, Non-Hygroscopic Soda Lime USP-NF, Type: High Moisture (12% to 19%), Granule Size: 4 to 10 Mesh (4.8-2. Terminated |
CBL | None listed |
| Sep 10, 2009 | Allied Healthcare Products Inc First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a shipping container labeled as: Product Terminated |
ECX | None listed |
| Sep 10, 2009 | Allied Healthcare Products Inc Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #65261-E, Desc D PORTABLE W STRAIGHT POS, Catalog #65261-E. The brand and firm name on the label affixed to the c Terminated |
ECX | None listed |
| Sep 10, 2009 | Allied Healthcare Products Inc Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product 0022-96, Desc CYL 02 ASSY., 637.2 LITER, Catalog #31-10-0017. The brand and firm name on the label affixed Terminated |
ECX | None listed |
| Sep 10, 2009 | Allied Healthcare Products Inc Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-96P, Desc CYL 02, JUMBO D, W/TYPE B POST, Catalog #31-10-2017. The brand and firm name on the label a Terminated |
ECX | None listed |
| Sep 10, 2009 | Allied Healthcare Products Inc Empty Jumbo D aluminum oxygen cylinders, 72 cylinders per skid labeled as: Product #0022-96D, Desc: CYL 02, JUMBO D, A VLV, 72/SKID, Catalog #31-10-0117. The brand and firm name on the label affixed Terminated |
ECX | None listed |
| Sep 10, 2009 | Allied Healthcare Products Inc Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-58 P, Desc CYL 02 ALUM 400 LITER, Catalog #31-10-2014. The brand and firm name on the label affixed to th Terminated |
ECX | None listed |
| Sep 10, 2009 | Allied Healthcare Products Inc Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-44P, CYL 02 ALUM 400 LITER, Catalog #31-10-0014. The brand and firm name on the label affixed to the cylind Terminated |
ECX | None listed |
| Sep 10, 2009 | Allied Healthcare Products Inc Empty M9 aluminum oxygen cylinders packaged in shipping containers (1 per container) labeled as: Product #0022-57P, Desc: CYL 02 ALUM 240 LITER, Catalog #31-10-2012. The brand and firm name on the la Terminated |
ECX | None listed |