Thayer Medical Corportation
Tucson, AZ, US
THAYER MEDICAL CORPORTATION appears in FDA device records in Tucson, AZ. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 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 Thayer Medical Corportation 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.
- Thayer Medical Corporation510(k), enforcement report, recall
510(k) clearance history
FDA records hold 19 510(k) clearances for Thayer Medical Corportation between 1988 and 2024. The busiest year on record is 1990, with 4. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 4 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2017 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | CAF | Substantially Equivalent | |
| K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber | NVP | Substantially Equivalent | |
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber | NVP | Substantially Equivalent | |
| K111570 | MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR | CAF | Substantially Equivalent | |
| K102658 | MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS | CAF | Substantially Equivalent | |
| K993101 | LITEAIRE | CAF | Substantially Equivalent | |
| K992722 | PRIMEAIRE | CAF | Substantially Equivalent | |
| K972237 | HAND HELD MEDISPACER | CAF | Substantially Equivalent | |
| K955805 | DUAL SPRAY MINISPACER | CAF | Substantially Equivalent | |
| K941026 | THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR | BZA | Substantially Equivalent | |
| K924535 | THAYER HAND HELD M.K.I. HOLDING CHAMBER | CAF | Substantially Equivalent | |
| K914283 | THAYER EXPANSION CHAMBER METERED DOSE INHALER | CAF | Substantially Equivalent | |
| K904917 | THAYER MIP ADAPTER | BXR | Substantially Equivalent | |
| K901739 | THAYER METERED DOSE INHALER DISPENSER/ADAPTER | CAI | Substantially Equivalent | |
| K900047 | THAYER SUCTION EVACUATION CONDENSATE COLLECTION | BYH | Substantially Equivalent | |
| K897057 | THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM | BYH | Substantially Equivalent | |
| K895479 | THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM | BYH | Substantially Equivalent | |
| K885088 | THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM | BYH | Substantially Equivalent | |
| K882341 | QUICK CONNECT T ADAPTOR | BZO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2026894 | 2026894 | THAYER MEDICAL CORPORTATION | 4575 S PALO VERDE RD STE 337, TUCSON, AZ 85714 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BZAConnector, Airway (Extension)
- BYHDrain, Tee (Water Trap)
- NVPHolding Chambers, Direct Patient Interface
- BXRMeter, Airway Pressure (Inspiratory Force)
- CAFNebulizer (Direct Patient Interface)
- BYIPercussor, Powered-Electric
- BZOSet, Tubing And Support, Ventilator (W Harness)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1146-2017 | Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The design of the actuator component of REF 1543A has been enhanced by the addition of a linear gear designed to increment the dose-counter on some pMDI canisters. REF 1543A provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs the medication through the dual orifices into the airstream | The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm O.D./I.D. Connections. | Class II | Terminated | |
| Z-1927-2012 | AirLife MiniSpacer MDI Dispenser Adapter. Dual-Spray MiniSpacer Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The MiniSpacer is not a metering valve, and does not measure the amount of medication dispensed. The device may also be used in conjunction with a resuscitator bag or in-line with cool or heated humidification, oxygen enriched T-pieces (blow-by) systems connected to tracheal/endotracheal tube. Environments of use include short and long term critical care settings. The 15 mm Dual Spray MiniSpacers design provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs it through the dual orifices into the airstream. Principles of Operation A healthcare practitioner installs the 15 mm MiniSpacer MDI adapter in the breathing circuit, according to facility procedures or as ordered by a physician or other licensed health care practitioner. To dispense the prescribed medication, the healthcare practitioner inserts the MDI canister stem into the devices actuator port and manually depresses the MDI canister. The MDI canisters metering valve releases the combination of medication and propellant through the valve stem and out of the devices dual spray nozzle. The plume is simultaneously ejected through upstream and downstream spray orifices along the longitudinal axis of the device. The practitioner administers the medication as prescribed, caps the MiniSpacer device, and monitors the patient response. The devices are packaged in cardboard corrugated cartons that are rated to meet burst testing up to 200 pounds per square inch. Each carton contains 30 devices; each device is packaged in a polybag with the instructions for use. These devices are sold non-sterile. | Internal data identified a molding defect in the 15 mm O.D. / I.D. MiniSpacer meter dose inhaler (MDI) adapter that results in an incomplete fill of the aerosol dispensing pathway. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain