BETA
Audubon, Pennsylvania manufacturer of prescription pneumatic compression devices and garments for lymphatic, venous and arterial conditions.
AIROS Medical was founded in 2016 and is headquartered in Audubon, Pennsylvania. President and CEO Gerald (Gerry) Makoid and COO Darren Behuniak are co-founders. The company develops compression systems for prescribed home therapy and clinical use, working with clinicians and durable medical equipment suppliers.
Its current portfolio comprises the six-chamber AIROS 6/6P and eight-chamber AIROS 8/8P families for lymphatic and venous conditions, plus the ARTAIRA arterial compression system. Seven FDA 510(k) decisions are mapped across those families. ARTAIRA has a distinct arterial indication set and should not be treated as interchangeable with the lymphatic/venous pumps.
AIROS acquired CircuFlow and ArterioFlow products and associated intellectual property from Devon Medical Products in 2018 and continues to offer support for those legacy lines. Current marketing is centered on AIROS-branded systems and ARTAIRA. Revenue, funding totals, installed-base size and independently verified comparative outcomes remain unconfirmed.
FDA Class II compressible-limb-sleeve devices, JOW, 21 CFR 870.5800, cleared through 510(k). ARTAIRA arterial labeling is distinct from AIROS lymphatic/venous labeling. [2][3][4][5][6][7][8][22][23][24][25][32]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [34][35]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Device-and-garment family with a peristaltic-mode 6P variant and upper-extremity, leg and compatible truncal garments. [26][2]
FDA-clearedCommercially available by prescription through professional and DME channels.
Device-and-garment family with adjustable chamber pressures and peristaltic-mode 8P variant; upper-extremity, leg and compatible truncal garments. [31][8]
FDA-clearedCommercially available by prescription through professional and DME channels.
Intermittent compression system delivering timed foot/ankle and calf compression, primarily for physician-prescribed home treatment. [29][4]
FDA-clearedCommercially available by prescription through professional and DME channels.
Commercial expansion includes peristaltic models, truncal garments and the ARTAIRA arterial line. No independently verified investigational program or comparative clinical-outcome claim asserted. [27][25][26][31][29]
FDA issued K240499 for the arterial compression device; commercial launch followed later. [4]
Company timeline identifies 8P and truncal garments in February and 6P and pants garments in September. [27]
FDA issued K223195 for AIROS 6P and K223193 for AIROS 8P. Clearance predates the 2023 commercial launches. [8]
FDA issued K193069 and K193068 for the respective device families. [7]
FDA issued K172770 and K172779; company timeline identifies a 2018 product launch. [5]
Company reports acquisition of three CircuFlow models, ArterioFlow 7500, garments, clearance numbers and other IP from Devon Medical Products. Purchase price not disclosed. [24]
Accessed 10/20/2026