Cleared Traditional

K952824 - NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR

K952824 is an FDA 510(k) clearance for NEO-LINK, manufactured by Intertex Medical, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K952824 · Intertex Medical, Inc. · Anesthesiology device
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Jul 1995
Decision
30d
Days
Class 1
Risk

K952824 is an FDA 510(k) clearance for the NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Intertex Medical, Inc. (New Canaan, US). The FDA issued a Cleared decision on July 20, 1995 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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 Intertex Medical, Inc. devices

FDA 510(k) Submission Details - K952824

510(k) Number K952824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1995
Decision Date July 20, 1995
Days to Decision 30 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

BZA Device Classification - Class 1, General Controls

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BZA Connector, Airway (extension)

All 59
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K952824.
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