Data / Medical devices / United States / Allied Medical LLC
Allied Medical LLC: FDA-registered device maker in Earth City, MO, United States, 61 510(k) clearances
Allied Medical LLC is registered with the FDA (registration 1924066) in Earth City, MO, United States. It lists 61 device types. The FDA files 61 510(k) clearances under its listings, the newest dated April 9, 2014. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1924066
- Address
- 13622 Lakefront Dr, Earth City, MO, United States, 63045
- Owner or operator
- Allied Medical LLC (9919025)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 14, 1992
- Registered through
- 2026
- Brand names listed
- ; HOSES, ADAPTERS, AEROSOL, AHP300 Ventilator, AIR PANTS, ALSO LSP OXYGEN REGULATOR., ANSAL, ASSEMBLIES and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 9, 2014 | K131098 | EMERGENCY PORTABLE VENTILATOR | BTL | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| April 2, 2014 | K132021 | AHP 300, EMERGENCY PORTABLE VENTILATOR | BTL | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| May 20, 2009 | K090356 | EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 | BTL | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| May 18, 2009 | K083507 | BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS | BTL | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| May 14, 2009 | K083385 | MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B | BTL | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| November 19, 2008 | K072634 | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | BTI | Substantially Equivalent | Emg Technology Co., Ltd. | accessdata.fda.gov |
| August 15, 2008 | K080063 | MASS CASUALTY VENTILATOR, MODEL MCV100 | BTL | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| March 6, 2008 | K072214 | PORTABLE VENTILATOR, MODEL EPV-100 | BTL | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| January 31, 2008 | K073171 | RESUSCITATION TIMER, MODEL L770-CPR | BTM | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| July 13, 2007 | K070636 | AUTOVENT 4000 WITH CPAP | BTL | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| May 3, 2007 | K070120 | AUTOVENT MODEL 4000 | BTL | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| October 18, 2006 | K062080 | RESUSCITATION TIMER, MODEL L770-CPR | BTM | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| December 14, 2005 | K052087 | BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178 | CAH | Substantially Equivalent | Ag Industries | accessdata.fda.gov |
| September 15, 2005 | K051260 | SCHUCO MIST AND SCHUCO DELUXE MIST | CAF | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| July 6, 2005 | K043238 | COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES | CAF | Substantially Equivalent | Emg Technology Co., Ltd. | accessdata.fda.gov |
| December 16, 2004 | K042349 | EMG MODEL SUA01 SUCTION UNIT | JCX | Substantially Equivalent | Emg Technology Co., Ltd. | accessdata.fda.gov |
| October 1, 2002 | K014071 | PMX DISPOSABLE BAG MASK RESUSCITATOR | BTM | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| March 14, 2001 | K010191 | Y2000 POCKET RESCUE | CBP | Substantially Equivalent | Cheen Houng Ent. Co. , Ltd. | accessdata.fda.gov |
| March 2, 2001 | K002468 | SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 | BTI | Substantially Equivalent | San UP S.A. | accessdata.fda.gov |
| March 25, 1998 | K980714 | BCI 3401 HANDHELD PULSE OXIMETER | DQA | Substantially Equivalent | Bci Intl., Inc. | accessdata.fda.gov |
| January 29, 1998 | K973106 | GOLEMB DISPOSABLE BAG MASK RESUSCITATOR | BTM | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| February 16, 1996 | K955129 | OXYPULSE EOC I, EOC II & EOC R | NFB | Substantially Equivalent | Eagle Medical Equipment Co. | accessdata.fda.gov |
| August 21, 1995 | K951729 | MEDI - PUMP | BTA | Substantially Equivalent | Thomas Industries | accessdata.fda.gov |
| April 19, 1995 | K950867 | MEDI - PUMP | CAF | Substantially Equivalent | Thomas Industries | accessdata.fda.gov |
| March 1, 1995 | K941547 | CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT | BYK | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| January 9, 1995 | K941871 | LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100 | BTL | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| January 9, 1995 | K941870 | LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100 | BTL | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| April 5, 1994 | K935218 | SCHUCO-VAC MODEL 178 | JCX | Substantially Equivalent | Schuco, Inc. | accessdata.fda.gov |
| January 12, 1994 | K925011 | NEBULIZER PUMP, POWERED MODEL 1180 | BTI | Substantially Equivalent | Thomas Industries | accessdata.fda.gov |
| November 24, 1993 | K932200 | LSPI AUTOMATIC VENTILATOR | BTL | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| November 24, 1993 | K932199 | LSPI AUTOMATIC VENTILATOR, MODEL AV3000 | BTL | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| November 24, 1993 | K922819 | INFANT DISPOSABLE BAG MASK RESUSCITATOR | BTM | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| November 24, 1993 | K922691 | LSP (MODEL 554) BAG MASK RESUSCITATOR | BTM | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| March 19, 1993 | K924100 | OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| October 19, 1992 | K921553 | LSPI INFANT BAG MASK | BTM | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| September 17, 1992 | K924217 | LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED | BTM | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| January 30, 1992 | K915564 | SPIROS | BTL | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| April 5, 1990 | K895956 | RX02 EMERGENCY MEDICAL OXYGEN | CAN | Substantially Equivalent | Progressive Medical Applications Corp. | accessdata.fda.gov |
| August 30, 1988 | K882219 | P.E.E.P. VALVE | BYE | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| June 14, 1988 | K881420 | OMNI-VENT, SERIES D/MRI | CBK | Substantially Equivalent | Stein-Gates Medical Equipment, Inc. | accessdata.fda.gov |
| March 23, 1988 | K872113 | OMNI-VENT, SERIES D | CBK | Substantially Equivalent | Stein-Gates Medical Equipment, Inc. | accessdata.fda.gov |
| January 22, 1988 | K870424 | LSP AUTOMATIC VENTILATOR, MODEL 456 | BTL | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| January 19, 1988 | K874656 | AUTOMATIC VENTILATOR AV2000 | BTL | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| April 9, 1986 | K861054 | DISPOSABLE RESCUE BREATHING DEVICE | CAE | Substantially Equivalent | B & F Medical Products, Inc. | accessdata.fda.gov |
| March 6, 1986 | K860180 | MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR | BTM | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| February 21, 1986 | K860516 | LSP MINILATOR | BXY | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| August 29, 1985 | K853004 | PORTABLE OXYGEN UNIT | CAW | Substantially Equivalent | B & F Medical Products, Inc. | accessdata.fda.gov |
| May 15, 1985 | K851337 | 502 RESUSCITATORY INHALATOR VALVE | BTL | Substantially Equivalent | Life Support Products, Inc. | accessdata.fda.gov |
| November 7, 1984 | K843691 | PORTABLE OXYGEN UNIT | CAW | Substantially Equivalent | B & F Medical Products, Inc. | accessdata.fda.gov |
| December 17, 1981 | K812766 | PCS-5 ACCESSORIES | BTI | Substantially Equivalent | Timeter Instrument Corp. | accessdata.fda.gov |
| October 26, 1981 | K812624 | OXEQUIP CONDUCTIVE & NON ANES. BREATH | CAI | Substantially Equivalent | Oxequip Health Ind. | accessdata.fda.gov |
| October 23, 1981 | K812564 | ZEE LIFE SUPPORT AIR PANTS | LHX | Substantially Equivalent | Zee Medical Products Co., Inc. | accessdata.fda.gov |
| June 9, 1981 | K811404 | TRAVELAIRE | CCQ | Substantially Equivalent | B & F Medical Products, Inc. | accessdata.fda.gov |
| March 13, 1981 | K810490 | GOMCO SUCTION PUMP CABINET CHANGE | BTA | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| December 22, 1980 | K802644 | EMERG. OXYGEN KIT #65350 & #65399 CASE | CAN | Substantially Equivalent | B & F Medical Products, Inc. | accessdata.fda.gov |
| February 28, 1980 | K800369 | TRI PAC MOUTH PROP | JXL | Substantially Equivalent | Oxequip Health Ind. | accessdata.fda.gov |
| May 21, 1979 | K790912 | ARIDYNE 3500 | BTI | Substantially Equivalent | Timeter Instrument Corp. | accessdata.fda.gov |
| October 10, 1978 | K781537 | NEBULIZER/HUMIDIFIER | BTT | Substantially Equivalent | Chemetron Medical Products, Inc. | accessdata.fda.gov |
| September 26, 1977 | K771707 | ADIDYNE 3000 | BTI | Substantially Equivalent | Timeter Instrument Corp. | accessdata.fda.gov |
| March 16, 1977 | K770424 | OXYGEN TWMER, MODEL SST | BXP | Substantially Equivalent | Timeter Instrument Corp. | accessdata.fda.gov |
| September 27, 1976 | K760680 | INTERMITTENT MANDATORY VENTILATION | CBO | Substantially Equivalent | B & F Medical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 12, 2010 | 57044 | Not yet classified | Terminated | 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- | The granules do not absorb as long as expected in the anesthesia machines | accessdata.fda.gov |
| May 15, 2009 | 52383 | Not yet classified | Terminated | 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 cy | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Emergency, Powered (Resuscitator)
- All makers of Burnisher, Operative
- All makers of Compressor, Air, Portable
- All makers of Generator, Oxygen, Portable
- All makers of Regulator, Vacuum
- All makers of Ventilator, Emergency, Manual (Resuscitator)
Updated April 9, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.