Cleared Traditional

K182573 - Hailie Sensor

K182573 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 262-day FDA review.

K182573 · Adherium (Nz), Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
262d
Days
Class 2
Risk

K182573 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 7, 2019 after a review of 262 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 - K182573

510(k) Number K182573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2018
Decision Date June 07, 2019
Days to Decision 262 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
122d slower than avg
Panel avg: 140d · This submission: 262d
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 K182573.
Proneb Max
K191270 · Pari Respiratory Equipment, Inc. · Jan 2020
CapMedic
K183586 · Cognita Labs, LLC · Sep 2019
Hailie Sensor
K182638 · Adherium (Nz), Ltd. · Jun 2019
Hailie Sensor
K181405 · Adherium (Nz), Ltd. · Dec 2018
Portable Nebulizer
K180871 · Microbase Technology Corporation · Sep 2018
Intelligent Mesh Nebulizer
K171549 · Qingdao Future Medical Technology Co., Ltd. · Aug 2018