Cleared Special

VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr

K251466 · Wellell, Inc. · Cardiovascular

Oct 2025

Decision

168d

Days

Class 2

Risk

About This 510(k) Submission

K251466 is an FDA 510(k) clearance for the VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Wellell, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on October 28, 2025, 168 days after receiving the submission on May 13, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number	K251466 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 2025
Decision Date	October 28, 2025
Days to Decision	168 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF