Cleared Traditional

K895031 - MODIFIED INFANT NASAL CANNULAE ASSEMBLY

K895031 is an FDA 510(k) clearance for MODIFIED INFANT NASAL CANNULAE ASSEMBLY, manufactured by Ackrad Laboratories. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 83-day FDA review.

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

FDA 510(k) Submission Details - K895031

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
Combination Product No
PCCP Authorized No
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.

BZD Device Classification - Class 2, Special Controls

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 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K895031.
SLEEPER MASK SYSTEM
K904344 · Devilbiss Health Care, Inc. · May 1991
DEVILBISS MODEL 7352 SERIES
K904766 · Devilbiss Health Care, Inc. · Mar 1991
RESPIRONICS BIPAP REMOTE CONTROL UNIT
K905540 · Respironics, Inc. · Jan 1991
H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP
K871351 · Holter-Hausner Intl. · May 1987
C.P.A.P. NASAL CANNULA
K871157 · Hudson Oxygen Therapy Sales Co. · Apr 1987
BIRD NIGHTBIRD NASAL CPAP SYSTEM
K863746 · Bird Products Corp. · Dec 1986