Cleared Traditional

K182638 - Hailie Sensor

K182638 is an FDA 510(k) clearance for Hailie Sensor, manufactured by Adherium (Nz), Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K182638 · Adherium (Nz), Ltd. · Anesthesiology device
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Jun 2019
Decision
268d
Days
Class 2
Risk

K182638 is an FDA 510(k) clearance for the Hailie Sensor. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Adherium (Nz), Ltd. (Auckland, NZ). The FDA issued a Cleared decision on June 19, 2019 after a review of 268 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Adherium (Nz), Ltd. devices

FDA 510(k) Submission Details - K182638

510(k) Number K182638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date June 19, 2019
Days to Decision 268 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 140d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 196
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K182638.
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Hailie Sensor
K182573 · Adherium (Nz), Ltd. · Jun 2019
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K180871 · Microbase Technology Corporation · Sep 2018