Cleared Traditional

K911804 - INFRASONICS VENTILATOR ADULT STAR, MODIFICATION

K911804 is an FDA 510(k) clearance for INFRASONICS VENTILATOR ADULT STAR, manufactured by Infrasonics Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 414-day FDA review.

K911804 · Infrasonics Corp. · Anesthesiology device
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Jun 1992
Decision
414d
Days
Class 2
Risk

K911804 is an FDA 510(k) clearance for the INFRASONICS VENTILATOR ADULT STAR, MODIFICATION. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Infrasonics Corp. (San Diego, US). The FDA issued a Cleared decision on June 11, 1992 after a review of 414 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 Infrasonics Corp. devices

FDA 510(k) Submission Details - K911804

510(k) Number K911804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1991
Decision Date June 11, 1992
Days to Decision 414 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
274d slower than avg
Panel avg: 140d · This submission: 414d
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 326
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K911804.
MODEL 6213 REMOTE ALARM
K914424 · Aequitron Medical, Inc. · Sep 1992
MODEL 105 VENTILATOR, MODIFICATION
K922477 · Infrasonics Corp. · Aug 1992
MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN
K915312 · Puritan Bennett Corp. · Jul 1992
BEAR 7 VENTILATOR
K912619 · Bear Medical Systems, Inc. · Jun 1992
HAYEK OSCILLATOR, MODIFICATION
K921726 · Respironics, Inc. · Apr 1992
LIFECARE REMOTE ALARM II
K913423 · Lifecare Services, Inc. · Jan 1992