Sansa Hsat

FDA 510(k) K250882 · Huxley Medical

Substantially Equivalent

510(k) numberK250882

Submission

Device name
Sansa Hsat
Applicant
Huxley Medical
Atlanta, GA, US
Received
March 24, 2025
Decision date
October 29, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNR – Ventilatory Effort Recorder
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2375
Specialty
Anesthesiology

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K253148RX-1 SleepMNR · Traditional Vivaquant, Inc. Dba Rhythm Express06/22/2026SE
K252628CassieMNR · Traditional Wesper, Inc.04/27/2026SE
K252497Sansa HsatMNR · Traditional Huxley Medical12/10/2025SE
K250460WatchPAT400 (WP400)MNR · Traditional Itamar Medical , Ltd.09/05/2025SE
K252383Somfit DMNR · Special Compumedics Limited08/28/2025SE
K243220Onera STS 2 (ONERA STS 2)MNR · Traditional Onera B.V.07/03/2025SE
K242224Happy Health Home Sleep TestMNR · Traditional Happy Health, Inc.06/18/2025SE
K243092AcuPebble Ox (200)MNR · Traditional Acurable Limited03/19/2025SE

More from Acurable Limited

510(k)DeviceDecision
K252497Sansa HsatMNR · Traditional 12/10/2025SE
K244027Sansa HsatMNR · Special 01/28/2025SE
K240285Huxley SANSA Home Sleep Apnea Test (1000-00)MNR · Traditional 07/15/2024SE

Questions and answers

When was Sansa Hsat cleared by the FDA?

Sansa Hsat (K250882) received a 510(k) decision of Substantially Equivalent on October 29, 2025, 219 days after the submission was received.

What is the product code of K250882?

The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.