Data / Medical devices / United States / Parks Medical Electronics, Inc.
Parks Medical Electronics, Inc.: FDA-registered device maker in Aloha, OR, United States, 1 510(k) clearance
Parks Medical Electronics, Inc. is registered with the FDA (registration 3020115) in Aloha, OR, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 2, 1995. 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
- 3020115
- Address
- 19460 SW Shaw ST, Aloha, OR, United States, 97007
- Owner or operator
- PARKS MEDICAL ELECTRONICS, INC. (9930003)
- Roles
- Manufacturer
- First device listed
- March 20, 2008
- Registered through
- 2026
- Brand names listed
- 2100-SX, 641-A; 614-B; 611-L; 917, 811-B; 811-BL; 811-BTS; 842; 909; 841-A; 801-B; 812; 840; 915-BL; 806-CB; 810-A; 810-B
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Flowmeter, Blood, Cardiovascular | DPW | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Heart Sound, Fetal, Ultrasonic | HEK | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Manufacturer | accessdata.fda.gov |
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic | JOP | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Obstetric | HGL | 2 | 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 |
|---|---|---|---|---|---|---|
| June 2, 1995 | K944495 | MODEL 3200 VASCULAR MINI-LAB | MHX | Substantially Equivalent | Parks Medical Electronics, 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 8, 2012 | 63235 | Class II | Terminated | Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models | Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff. | accessdata.fda.gov |
| November 8, 2007 | 45800 | Not yet classified | Terminated | Parks Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007 | Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter. | accessdata.fda.gov |
Compare with other makers
- All makers of Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- All makers of Transducer, Ultrasonic, Obstetric
- All makers of Flowmeter, Blood, Cardiovascular
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- All makers of Transducer, Ultrasonic
Updated December 10, 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.