Allied Medical LLC
Stuyvesant Falls, NY, US
Allied Medical LLC appears in FDA device records in Stuyvesant Falls, NY. FDA records list 26 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Allied Medical LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Allied Healthcare Products, Inc.510(k), recall
510(k) clearance history
FDA records hold 26 510(k) clearances for Allied Medical LLC between 1981 and 2014. The busiest year on record is 1981, with 6. The most recent is 2014, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 6 |
| 1982 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2002 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 3 |
| 2014 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131098 | EMERGENCY PORTABLE VENTILATOR | BTL | Substantially Equivalent | |
| K132021 | AHP 300, EMERGENCY PORTABLE VENTILATOR | BTL | Substantially Equivalent | |
| K090356 | EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 | BTL | Substantially Equivalent | |
| K083507 | BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS | BTL | Substantially Equivalent | |
| K083385 | MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B | BTL | Substantially Equivalent | |
| K080063 | MASS CASUALTY VENTILATOR, MODEL MCV100 | BTL | Substantially Equivalent | |
| K072214 | PORTABLE VENTILATOR, MODEL EPV-100 | BTL | Substantially Equivalent | |
| K073171 | RESUSCITATION TIMER, MODEL L770-CPR | BTM | Substantially Equivalent | |
| K070636 | AUTOVENT 4000 WITH CPAP | BTL | Substantially Equivalent | |
| K070120 | AUTOVENT MODEL 4000 | BTL | Substantially Equivalent | |
| K062080 | RESUSCITATION TIMER, MODEL L770-CPR | BTM | Substantially Equivalent | |
| K051260 | SCHUCO MIST AND SCHUCO DELUXE MIST | CAF | Substantially Equivalent | |
| K014071 | PMX DISPOSABLE BAG MASK RESUSCITATOR | BTM | Substantially Equivalent | |
| K973106 | GOLEMB DISPOSABLE BAG MASK RESUSCITATOR | BTM | Substantially Equivalent | |
| K972203 | BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K955865 | BEAR CUB INFANT PRESSURE VENTILATOR | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K941547 | CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT | BYK | Substantially Equivalent | |
| K932936 | L.A.P. II SPRIOMETRY SYSTEM | BZG | Substantially Equivalent | |
| K924100 | OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | |
| K822614 | BLOOD PRESSURE MONITORING DEVICES | DXN | Substantially Equivalent | |
| K811260 | BARALYME CO2 ABSORBENT | CBL | Substantially Equivalent | |
| K810939 | NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI. | BTT | Substantially Equivalent | |
| K810938 | MASS SPECTROMETER-MEDSPECT II | DOP | Substantially Equivalent | |
| K810927 | RESPIRATORY INTENSIVE CARE SYSTEM (RICS) | CCK | Substantially Equivalent | |
| K810585 | SARA | CBS | Substantially Equivalent | |
| K810490 | GOMCO SUCTION PUMP CABINET CHANGE | BTA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1314798 | 1314798 | Allied Medical LLC | 46 New Street, STUYVESANT FALLS, NY 12174 US | 2026 | |
| 1924066 | 1924066 | Allied Medical LLC | 13622 Lakefront Dr, Earth City, MO 63045 US | 2026 | and 51 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CBLAbsorbent, Carbon-Dioxide
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- CBOAttachment, Intermittent Mandatory Ventilation (Imv)
- JXLBlock, Bite
- EKJBurnisher, Operative
- BRYCabinet, Table And Tray, Anesthesia
- BXXCalibrator, Pressure, Gas
- BXWCalibrator, Volume, Gas
- CATCannula, Nasal, Oxygen
- BZBCatheter, Nasal, Oxygen
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- HFXClamp, Circumcision
- BXJClip, Nose
- BTICompressor, Air, Portable
- HCYCurette, Uterine
- FMRDevice, Transfer, Patient, Manual
- BYHDrain, Tee (Water Trap)
- CAHFilter, Bacterial, Breathing-Circuit
- BXYFlowmeter, Calibration, Gas
- CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated
- CAWGenerator, Oxygen, Portable
- EJBHandle, Instrument, Dental
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- BYGMask, Oxygen
- BYFMask, Oxygen, Low Concentration, Venturi
- DOPMass Spectrometer, Clinical Use
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- DQAOximeter
- JPWPump, Nebulizer, Electrically Powered
- BTAPump, Portable, Aspiration (Manual Or Powered)
- JRERefractometer For Clinical Use
- CANRegulator, Pressure, Gas Cylinder
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BZGSpirometer, Diagnostic
- FZFSplint, Extremity, Inflatable, External
- BTKStrap, Head, Gas Mask
- FPPStretcher, Hand-Carried
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- BYLTent, Oxygen
- BYKTent, Oxygen, Electrically Powered
- BXPTransducer, Gas Flow
- BYYTube, Aspirating, Flexible, Connecting
- GAZTubing, Noninvasive
- BYXTubing, Pressure And Accessories
- EBRUnit, Suction Operatory
- CBPValve, Non-Rebreathing
- CBKVentilator, Continuous, Facility Use
- BTMVentilator, Emergency, Manual (Resuscitator)
- BTLVentilator, Emergency, Powered (Resuscitator)
- BZDVentilator, Non-Continuous (Respirator)
- CAMYoke Assembly, Medical Gas
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2152-2011 | 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 (4.8-2.0mm), packaged in 5-gal. pails, #55-01-0003; prepacked canisters (12 canisters/case), #55-01-0005; and replacement bags (12 bags/case), #55-01-0006, RX. The label shows the product is Manufactured by Allied Healthcare Products Inc., St. Louis, MO. The product is a non-hygroscopic soda lime compound that is specially formulated to absorb carbon dioxide from the respiratory gas stream in anesthesia applications. | The granules do not absorb as long as expected in the anesthesia machines | Terminated | ||
| Z-2038-2009 | 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 #L903, Desc FIRST RESPONDER KIT, Catalog #L903. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO. | Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position. | Terminated | ||
| Z-2037-2009 | 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 cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO. | Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position. | Terminated | ||
| Z-2036-2009 | 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 to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO. | Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position. | Terminated | ||
| Z-2035-2009 | 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 affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO. | Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position. | Terminated | ||
| Z-2034-2009 | 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 to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO. | Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position. | Terminated | ||
| Z-2033-2009 | 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 the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO. | Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position. | Terminated | ||
| Z-2032-2009 | 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 cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO. | Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position. | Terminated | ||
| Z-2031-2009 | 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 label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO. | Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain