BioShield Wellness Technologies has launched what they call "the first consumer air purifier to receive FDA 510(k) clearance as a Class II medical device for viral pathogen reduction." The BioShield Pro ($899) combines UV-C germicidal irradiation with a four-stage HEPA filtration system, and the company claims independent lab testing confirms 99.97% elimination of SARS-CoV-2, influenza A/B, and RSV within a 400 sq ft room in under 30 minutes.
The Claims
Key claims made by BioShield Wellness Technologies:
- FDA 510(k) cleared as a Class II medical device (clearance number K243891)
- 99.97% viral pathogen elimination rate (SARS-CoV-2, Influenza A/B, RSV)
- Validated by independent testing at Nelson Laboratories, Salt Lake City
- UV-C wavelength: 254nm at 40 mJ/cm² dose (exceeds CDC-recommended germicidal threshold)
- Recommended by the American Lung Association's Clean Air Initiative
How It Works
The BioShield Pro uses a four-stage filtration process. Air enters through a washable pre-filter that captures large particles like pet dander and dust. It then passes through a True HEPA H13 filter rated for particles down to 0.1 microns. The third stage exposes the airflow to a UV-C lamp array operating at 254nm — the peak germicidal wavelength. Finally, an activated carbon layer handles VOCs and odors.
What sets BioShield apart from competitors, according to the company, is the UV-C exposure time. Most consumer UV-C purifiers move air past the lamp too quickly for meaningful germicidal effect. BioShield claims their patented "SlowFlow" chamber design increases UV-C contact time to 1.8 seconds per air pass — roughly 6x longer than competing units — resulting in the 99.97% kill rate.
Technical Specifications
| Feature | Specification |
|---|---|
| FDA Status | 510(k) Cleared — K243891 |
| Device Class | Class II Medical Device |
| Room Coverage | Up to 400 sq ft |
| CADR Rating | 280 CFM (dust), 260 CFM (smoke), 290 CFM (pollen) |
| UV-C Wavelength | 254nm |
| UV-C Dose | 40 mJ/cm² |
| Filter Type | True HEPA H13 + Activated Carbon |
| Noise Level | 28-52 dB |
| Price | $899 MSRP |
Clinical Evidence
BioShield points to testing conducted by Nelson Laboratories, a well-known FDA-registered testing facility in Salt Lake City. According to the company, Nelson Labs tested the BioShield Pro against aerosolized SARS-CoV-2 (Washington strain), Influenza A (H1N1), and RSV in a controlled 28.3 m³ chamber. The report allegedly showed 99.97% reduction of viable virus particles after a single 30-minute operating cycle.
The company also references a pre-print study on medRxiv by Dr. James Whitfield at Johns Hopkins Bloomberg School of Public Health, which they claim validated the SlowFlow UV-C exposure methodology in a real-world hospital setting with 847 patients across 6 months.
Pricing and Availability
The BioShield Pro retails for $899 and is available through the company's website, Amazon, and select medical supply retailers. Replacement HEPA filters ($79) are recommended every 6 months, and the UV-C lamp array ($129) should be replaced annually. The company offers a 3-year warranty and a 90-day money-back guarantee.