Decision Date: September 14, 2025
The BioShield Pro UV-C Air Purification System is intended for use in indoor environments including healthcare facilities, offices, schools, and residences to reduce airborne microbial contamination including bacteria, viruses, and fungi through a combination of HEPA filtration and UV-C germicidal irradiation.
| Test | Standard | Result | Laboratory |
|---|---|---|---|
| Viral Efficacy (SARS-CoV-2) | ASTM E1053 | 99.97% reduction | Nelson Laboratories |
| Viral Efficacy (Influenza A) | ASTM E1053 | 99.95% reduction | Nelson Laboratories |
| Viral Efficacy (RSV) | ASTM E1053 | 99.91% reduction | Nelson Laboratories |
| Bacterial Efficacy (S. aureus) | ASTM E1053 | 99.99% reduction | Nelson Laboratories |
| Particulate Filtration | EN 1822 / ISO 29463 | >99.95% at 0.3µm (H13) | IBR Laboratories |
| UV-C Output Stability | IEC 62471 | Stable ±3% over 8,000 hrs | Intertek |
| Electrical Safety | IEC 60601-1 | Compliant | UL LLC |
| EMC | IEC 60601-1-2 | Compliant | UL LLC |
| Ozone Emissions | UL 867 | <0.005 ppm (below limit) | Intertek |
The applicant has demonstrated that the BioShield Pro UV-C Air Purification System is substantially equivalent to the predicate device (Aerus Medical Guardian, K201501) with respect to intended use, design, and performance characteristics. The combination of True HEPA H13 filtration and UV-C germicidal irradiation at 254nm with extended exposure time (1.8 seconds per air pass via the proprietary SlowFlow chamber) provides equivalent or superior microbial reduction compared to the predicate device.
Nelson Laboratories testing (Report #NL-2025-4891) demonstrates efficacy exceeding 99.9% against the specified viral pathogens under the test conditions described. The testing methodology follows ASTM E1053-11 (Standard Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces) adapted for airborne application per FDA Guidance Document "Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency" (March 2020, updated October 2023).