Cleared Traditional

K183586 - CapMedic

K183586 is an FDA 510(k) clearance for CapMedic, manufactured by Cognita Labs, LLC. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K183586 · Cognita Labs, LLC · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
266d
Days
Class 2
Risk

K183586 is an FDA 510(k) clearance for the CapMedic. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Cognita Labs, LLC (Santa Ana, US). The FDA issued a Cleared decision on September 13, 2019 after a review of 266 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 Cognita Labs, LLC devices

FDA 510(k) Submission Details - K183586

510(k) Number K183586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2018
Decision Date September 13, 2019
Days to Decision 266 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
126d slower than avg
Panel avg: 140d · This submission: 266d
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 349
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K183586.
GUS831 Compressor Nebulizer
K192633 · Globalcare Medical Technology Co., Ltd. · May 2020
Propeller Sensor for Symbicort
K192724 · Reciprocal Labs Corporation · Mar 2020
Proneb Max
K191270 · Pari Respiratory Equipment, Inc. · Jan 2020
Hailie Sensor
K182638 · Adherium (Nz), Ltd. · Jun 2019
Hailie Sensor
K182573 · Adherium (Nz), Ltd. · Jun 2019
Hailie Sensor
K181405 · Adherium (Nz), Ltd. · Dec 2018