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510(k) K252497

SANSA HSAT by Huxley Medical — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2025
Date Received
August 8, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Huxley Medical

  • K250882 — SANSA HSAT (October 29, 2025)
  • K244027 — SANSA HSAT (January 28, 2025)
  • K240285 — Huxley SANSA Home Sleep Apnea Test (1000-00) (July 15, 2024)

Other clearances for product code MNR

  • K250882 — SANSA HSAT (October 29, 2025)
  • K250460 — WatchPAT400 (WP400) (September 5, 2025)
  • K252383 — Somfit D (August 28, 2025)
  • K243220 — Onera STS 2 (ONERA STS 2) (July 3, 2025)
  • K242224 — Happy Health Home Sleep Test (June 18, 2025)
  • K243092 — AcuPebble Ox (200) (March 19, 2025)
  • K243268 — TipTraQ (TTQ001) (February 3, 2025)
  • K244027 — SANSA HSAT (January 28, 2025)
  • K242290 — DormoTech NLab (January 8, 2025)
  • K242424 — Bluebird Single-Use Respiratory Effort Belt (December 18, 2024)