Chrysalis Intelligence · Product Codes · FRA

FRA · Unclassified

18 clearances · 14 unique sponsors

Device class
Regulation —
Total clearances
18
2020-04-15 → 2025-09-15
Last 12 months
1
Unique sponsors
14
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Molekule, Inc. 3 0 2021-08-20
Healkee Medical Pte, Ltd. 2 0 2024-05-23
Aeroclean Technologies, Inc. 2 0 2022-11-30
Uvx, Inc. 1 1 2025-09-15
Applied Photonix, LLC 1 0 2024-08-01
Bluezone Products, Inc. 1 0 2022-02-17
Aerus Medical, LLC 1 0 2020-06-17
Invictus Lighting 1 0 2022-05-26
Samsung Electronics Co., Ltd. 1 0 2021-11-26
Genesis Air, Inc. 1 0 2023-06-02
Guangzhou Ajax Medical Equipment Co., Ltd. 1 0 2021-06-11
Aerobiotix, Inc. 1 0 2021-01-21
Synexis, LLC 1 0 2023-06-14
Airgle Corporation 1 0 2024-02-16
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
E1601 HCPCS High Standard HCPCS code for continuous positive airway pressure (CPAP) and related medical air/UV purification equipment rental
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-09-15 K252128 Uvx, Inc. Zener® (model ZEN-001-B1)
2024-08-01 K241140 Applied Photonix, LLC ViroZap Indoor Air Purifier, In Duct Model 1008
2024-05-23 K232642 Healkee Medical Pte, Ltd. AirKEE T900
2024-05-16 K232933 Healkee Medical Pte, Ltd. AirKEE P900
2024-02-16 K232645 Airgle Corporation Airgle Room Air Purifier
2023-06-14 K221540 Synexis, LLC Synexis Sphere Rx
2023-06-02 K222702 Genesis Air, Inc. RGS; RGS Mini
2022-11-30 K223328 Aeroclean Technologies, Inc. Purgo
2022-06-01 K213753 Aeroclean Technologies, LLC Purgo
2022-05-26 K212644 Invictus Lighting Aura Storm
2022-02-17 K212824 Bluezone Products, Inc. Bluezone Model RX-450 Air Purifier
2021-11-26 K211139 Samsung Electronics Co., Ltd. CUBE Air Purifier
2021-08-20 K211194 Molekule, Inc. Molekule Air Pro
2021-06-11 K202766 Guangzhou Ajax Medical Equipment Co., Ltd. EOS Air Cleaner
2021-02-23 K202339 Molekule, Inc. Molekule Air Mini, Molekule Air Mini +
2021-01-21 K203189 Aerobiotix, Inc. AEROCURE-MD
2020-06-17 K201220 Aerus Medical, LLC Aerus Medical Guardian,model F170A
2020-04-15 K200500 Molekule, Inc. Molekule Air Pro RX