Cleared Traditional

K914916 - ALPINE V

K914916 is an FDA 510(k) clearance for ALPINE V, manufactured by Mountain Medical Equipment, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K914916 · Mountain Medical Equipment, Inc. · Anesthesiology device
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Sep 1992
Decision
324d
Days
Class 2
Risk

K914916 is an FDA 510(k) clearance for the ALPINE V. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Mountain Medical Equipment, Inc. (Littleton, US). The FDA issued a Cleared decision on September 23, 1992 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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. Elevated predicate reliance profile. 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 Mountain Medical Equipment, Inc. devices

FDA 510(k) Submission Details - K914916

510(k) Number K914916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1991
Decision Date September 23, 1992
Days to Decision 324 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 140d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 120
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K914916.
OXYGEN CONCENTRATOR
K924100 · Allied Healthcare Products, Inc. · Mar 1993
SCOTTY
K923650 · Mountain Medical Equipment, Inc. · Jan 1993
OH-500 OXYGEN CONCENTRATOR
K924146 · Healthdyne, Inc. · Jan 1993
MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS
K914488 · Invacare Corp. · Sep 1992
PORTABLE OXYGEN GENERATOR
K915381 · Aequitron Medical, Inc. · Mar 1992
MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON
K904087 · Invacare Corp. · Oct 1990