Cleared Traditional

K990321 - ALPHAMED GEMINI SENSOR, SNORING SENSOR

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

K990321 · Alphamed, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K990321

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
Combination Product No
PCCP Authorized No
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.

MNR Device Classification - Class 2, Special Controls

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 109
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K990321.
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