Cleared Traditional

K901448 - VEOLAR VENTILATOR

K901448 is an FDA 510(k) clearance for VEOLAR VENTILATOR, manufactured by Hamilton Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 632-day FDA review.

K901448 · Hamilton Medical, Inc. · Anesthesiology device
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Dec 1991
Decision
632d
Days
Class 2
Risk

K901448 is an FDA 510(k) clearance for the VEOLAR VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Hamilton Medical, Inc. (Reno, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 632 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Hamilton Medical, Inc. devices

FDA 510(k) Submission Details - K901448

510(k) Number K901448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1990
Decision Date December 20, 1991
Days to Decision 632 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
492d slower than avg
Panel avg: 140d · This submission: 632d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K901448.
HAYEK OSCILLATOR, MODIFICATION
K921726 · Respironics, Inc. · Apr 1992
LIFECARE REMOTE ALARM II
K913423 · Lifecare Services, Inc. · Jan 1992
STAR SYNC, MODIFICATION
K913972 · Infrasonics Corp. · Jan 1992
BIRD NEBULIZATION SYNCHRONIZER
K911336 · Bird Products Corp. · Nov 1991
VENTILATOR STAND
K914485 · Bird Products Corp. · Oct 1991
NARKOMED AV-E VENTILATOR
K912533 · Draeger Medical, Inc. · Jul 1991