Cleared Traditional

K233580 - A Breathing System (ABS)

K233580 is an FDA 510(k) clearance for A Breathing System (ABS), manufactured by Deepwell Dtx, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K233580 · Deepwell Dtx, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
268d
Days
Class 2
Risk

K233580 is an FDA 510(k) clearance for the A Breathing System (ABS). Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Deepwell Dtx, Inc. (Seattle, US). The FDA issued a Cleared decision on August 1, 2024 after a review of 268 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Deepwell Dtx, Inc. devices

FDA 510(k) Submission Details - K233580

510(k) Number K233580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2023
Decision Date August 01, 2024
Days to Decision 268 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 148d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 Neurology devices follow this clearance model.

Regulatory Peers - HCC Device, Biofeedback

All 7
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K233580.
Prism
K222101 · Graymatters Health , Ltd. · Mar 2023
Freespira
K180173 · Palo Alto Health Sciences, Inc. · Aug 2018
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular · Aug 2004
SONDREX P.A.L. SYSTEM
K010388 · Ohmeda Medical · Dec 2001
EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001
EMG RETRAINER
K972487 · Chattanooga Group, Inc. · Sep 1997