Cleared Traditional

K990321 - ALPHAMED GEMINI SENSOR

K990321 is the FDA 510(k) clearance for ALPHAMED GEMINI SENSOR by Alphamed, Inc.. It is a Class 2 Anesthesiology device (product code MNR) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K990321 · Alphamed, Inc. · Anesthesiology device
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Jun 1999
Decision
120d
Days
Class 2
Risk

K990321 is an FDA 510(k) clearance for the ALPHAMED GEMINI SENSOR, SNORING SENSOR. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Alphamed, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 1, 1999 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alphamed, Inc. devices

Submission Details

510(k) Number K990321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1999
Decision Date June 01, 1999
Days to Decision 120 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 140d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 61
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K990321.
BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
K051313 · Salter Labs · Sep 2005
STARDUST II, MODEL 1011176
K021845 · Respironics, Inc. · May 2004
SUZANNE
K990565 · Nellcor Puritan Bennett, Inc. · Aug 1999
SMARTRECORDER, MODEL 2500
K990199 · Respironics, Inc. · Apr 1999
STARDUST
K973920 · Respironics, Inc. · May 1998
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
K971501 · Bio-Logic Systems Corp. · Oct 1997