Aerloom

FDA 510(k) K254217 · Evolym, LLC

Substantially Equivalent

510(k) numberK254217

Submission

Device name
Aerloom
Applicant
Evolym, LLC
Wilmington, DE, US
Received
December 29, 2025
Decision date
August 31, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOW – Sleeve, Limb, Compressible
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5800
Specialty
Cardiovascular

Other 510(k)s with product code JOW

510(k)DeviceApplicantDecision
K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)JOW · Traditional Bio Compression Systems, Inc.09/11/2026SE
K253555Flexitouch® Plus Advanced Pneumatic Compression SystemJOW · Traditional Tactile Medical07/31/2026SE
K253386DVT GarmentJOW · Traditional Vistar Medical Supplies Co., Ltd.06/25/2026SE
K250242Compression Therapy Device (LGT-2202DVT)JOW · Traditional Guangzhou Longest Medical Technology Co., Ltd.04/24/2026SE
K254267NanoPress 760A-BT (760A-BT)JOW · Traditional Mego Afek , Ltd.02/24/2026SE
K250974Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional Bio Compression Systems, Inc.12/12/2025SE
K250190Sequential Compression System (SCD600)JOW · Traditional Shenzhen Comen Medical Instruments Co.,Ltd12/08/2025SE
K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special Wellell, Inc.10/28/2025SE
K251446PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special Manamed, LLC09/17/2025SE
K251086PnueAira (PNCU-01)JOW · Traditional Biotab, LLC08/18/2025SE

Questions and answers

When was Aerloom cleared by the FDA?

Aerloom (K254217) received a 510(k) decision of Substantially Equivalent on August 31, 2026, 245 days after the submission was received.

What is the product code of K254217?

The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.