Cleared Traditional

Hailie Sensor (K182638) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 75
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K182638.
Propeller Sensor for Symbicort
K192724 · Reciprocal Labs Corporation · Mar 2020
Proneb Max
K191270 · Pari Respiratory Equipment, Inc. · Jan 2020
CapMedic
K183586 · Cognita Labs, LLC · Sep 2019
Hailie Sensor
K182573 · Adherium (Nz), Ltd. · Jun 2019
Hailie Sensor
K181405 · Adherium (Nz), Ltd. · Dec 2018
Portable Nebulizer
K180871 · Microbase Technology Corporation · Sep 2018