MNR

Ventilatory Effort Recorder

Product code
MNR
Device name
Ventilatory Effort Recorder
Device class
Class 2
21 CFR
21 CFR 868.2375
Medical specialty
Anesthesiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
21
Summaries archived here
20 (direct download)
510(k) clearances (all years, FDA)
164 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (21)

Last three years. Most recent: 2026-07-31.

NumberDecision dateApplicantDevice nameSummary
K2540422026-07-31Itamar Medical , Ltd.WatchPAT SWPDF
K2600502026-07-15Huneo, LLCWRAP SystemPDF
K2531482026-06-22Vivaquant, Inc. Dba Rhythm ExpressRX-1 SleepPDF
K2526282026-04-27Wesper, Inc.CASSIEPDF
K2524972025-12-10Huxley MedicalSANSA HSATPDF
K2508822025-10-29Huxley MedicalSANSA HSATPDF
K2504602025-09-05Itamar Medical , Ltd.WatchPAT400 (WP400)PDF
K2523832025-08-28Compumedics LimitedSomfit DPDF
K2432202025-07-03Onera B.V.Onera STS 2 (ONERA STS 2)PDF
K2422242025-06-18Happy Health, Inc.Happy Health Home Sleep TestPDF
K2430922025-03-19Acurable LimitedAcuPebble Ox (200)PDF
K2432682025-02-03Pranaq Pte. , Ltd.TipTraQ (TTQ001)PDF
K2440272025-01-28Huxley MedicalSANSA HSATPDF
K2422902025-01-08Dormotech Medical, Ltd.DormoTech NLabPDF
K2424242024-12-18Cadwell Industries, Inc.Bluebird Single-Use Respiratory Effort BeltPDF
K2316672024-09-06WithingsWithings Sleep RxPDF
K2335012024-07-26Largan Medical Co., Ltd.“LARGAN Health AI-Tech” Sleep Apnea and Sleep Qualit…FDA
K2402852024-07-15Huxley MedicalHuxley SANSA Home Sleep Apnea Test (1000-00)PDF
K2401002024-06-04Snap Diagnostics, LLCSAM Model 9-10000PDF
K2313552024-02-09EnsodataAuroraPDF
K2315462023-11-30Compumedics LimitedSomfitPDF

20 summaries are archived here for direct download.

Official FDA classification page: MNR
Classification and pathway per current FDA publications. Data from openFDA (CC0).