Data / Medical devices / United States / Accutron, Inc.
Accutron, Inc.: FDA-registered device maker in Phoenix, AZ, United States, 6 510(k) clearances
Accutron, Inc. is registered with the FDA (registration 2020813) in Phoenix, AZ, United States. It lists 13 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 23, 2005. 1 recall event names it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2020813
- Address
- 1625 W Pinnacle Peak Rd, Phoenix, AZ, United States, 85027
- Owner or operator
- Accutron Inc (2020813)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- June 18, 1992
- Registered through
- 2027
- Brand names listed
- ACCUTRON, Apparatus, Gas-Scavenging, BAG, RESERVOIR, GAUGE, GAS PRESSURE, CYLINDER/PIPELINE, Gas-machine, anesthesia, REGULATOR, PRESSURE, GAS CYLINDER, TRANSDUCER, GAS PRESSURE, TUBING, PRESSURE AND ACCESSORIES and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Gas-Scavenging | CBN | 2 | Manufacturer | accessdata.fda.gov |
| Bag, Reservoir | BTC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Manufacturer | accessdata.fda.gov |
| Gas-Machine, Anesthesia | BSZ | 2 | Manufacturer | accessdata.fda.gov |
| Gauge, Gas Pressure, Cylinder/Pipeline | BXH | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Manufacturer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Transducer, Gas Pressure | BXO | 1 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Manufacturer | accessdata.fda.gov |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Yoke Assembly, Medical Gas | CAM | 1 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| November 23, 2005 | K052335 | ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA | BSZ | Substantially Equivalent | Accutron, Inc. | accessdata.fda.gov |
| March 12, 2004 | K033503 | RFS VACUUM GAUGE SCAVENGING CIRCUIT | CBN | Substantially Equivalent | Accutron, Inc. | accessdata.fda.gov |
| December 10, 1997 | K970163 | ALPHA MX (20)/ULTRA PC (30) | BSZ | Substantially Equivalent | Technical Medical Products, Inc. | accessdata.fda.gov |
| March 28, 1997 | K970046 | UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) | KHA | Substantially Equivalent | Accutron, Inc. | accessdata.fda.gov |
| March 28, 1997 | K965239 | PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) | CBN | Substantially Equivalent | Accutron, Inc. | accessdata.fda.gov |
| May 28, 1991 | K910040 | AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT | BTM | Substantially Equivalent | Ambu, 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 |
|---|---|---|---|---|---|---|
| April 29, 2012 | 63174 | Class I | Terminated | Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine. | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. | accessdata.fda.gov |
Compare with other makers
- All makers of Regulator, Pressure, Gas Cylinder
- All makers of Mask, Oxygen
- All makers of Apparatus, Gas-Scavenging
- All makers of Bag, Reservoir
- All makers of Transducer, Gas Pressure
- All makers of Ventilator, Emergency, Manual (Resuscitator)
Updated October 9, 2012. 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.