Cleared Traditional

MODIFIED INFANT NASAL CANNULAE ASSEMBLY (K895031) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895031 · Ackrad Laboratories · Anesthesiology device
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Oct 1989
Decision
83d
Days
Class 2
Risk

K895031 is an FDA 510(k) clearance for the MODIFIED INFANT NASAL CANNULAE ASSEMBLY. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Ackrad Laboratories (Cranford, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ackrad Laboratories devices

Submission Details

510(k) Number K895031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date October 30, 1989
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 122
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K895031.
RESPIRONICS REMSTAR WITH REMOTE AND RAMP
K911856 · Respironics, Inc. · Aug 1991
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
K905404 · Medtronic Vascular · May 1991
RESPIRONICS BIPAP REMOTE CONTROL UNIT
K905540 · Respironics, Inc. · Jan 1991
ARGYLE CPAP NASAL CANNULA
K811409 · Sherwood Medical Co. · Jun 1981