HCC · Class II · 21 CFR 882.5050

FDA Product Code HCC: Device, Biofeedback

Leading manufacturers include Thought Technology , Ltd., Bio-Feedback Systems, Inc. and Moe.

173
Total
173
Cleared
177d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 268d recently vs 176d historically

FDA 510(k) Cleared Device, Biofeedback Devices (Product Code HCC)

173 devices
1–24 of 173
Cleared Oct 30, 2026
AesyBite Active
K260360
Aesyra SA
Neurology · 268d
Cleared Aug 01, 2024
A Breathing System (ABS)
K233580
Deepwell Dtx, Inc.
Neurology · 268d
Cleared Mar 17, 2023
Prism
K222101
Graymatters Health , Ltd.
Neurology · 242d
Cleared Aug 23, 2018
Freespira
K180173
Palo Alto Health Sciences, Inc.
Neurology · 213d
Cleared Sep 01, 2017
GrindCare System
K163448
Sunstar Suisse S.A.
Neurology · 267d
Cleared Dec 22, 2015
Pacifier Activated Lullaby (PAL®)
K151050
Power Medical Devices, LLC
Neurology · 246d
Cleared Sep 09, 2015
NFANT Feeding Solution
K143507
Nfant Labs, LLC
Neurology · 273d
Cleared Dec 10, 2013
CANARY BREATHING SYSTEM
K131586
Palo Alto Health Sciences, Inc.
Neurology · 193d
Cleared Feb 06, 2013
EEGER4 MODEL 4.3
K122879
Eeg Software, LLC
Neurology · 140d
Cleared Sep 29, 2011
EMG SYSTEM
K111687
Myotronics-Noromed, Inc.
Neurology · 105d
Cleared Mar 03, 2010
GRINDCARE
K092675
Medotech A/S
Neurology · 183d
Cleared Feb 28, 2008
EEG NEUROAMP, MODEL CS10137
K073557
Corscience GmbH & Co. KG
Neurology · 71d
Cleared Feb 01, 2008
NTRAINER SYSTEM
K071866
Kcbiomedix, Inc.
Neurology · 210d
Cleared Sep 05, 2007
ALPHAONE BIOFEEDBACK SYSTEM
K071661
Telediagnostic Systems, Inc.
Neurology · 78d
Cleared Aug 12, 2004
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244
Medtronic Vascular
Neurology · 93d
Cleared Jul 02, 2002
RESPERATE
K020399
Intercure , Ltd.
Neurology · 146d
Cleared Dec 11, 2001
SONDREX P.A.L. SYSTEM
K010388
Ohmeda Medical
Neurology · 306d
Cleared Nov 13, 2001
MODEL MES-9000/EMG SYSTEM
K013399
Myotronics-Noromed, Inc.
Neurology · 29d
Cleared Oct 15, 2001
EAR MUFFINS
K012384
Bio-Logic Systems Corp.
Neurology · 80d
Cleared Oct 10, 2001
MODIFICATION TO A620 EEG
K012011
Stoelting Co.
Neurology · 104d
Cleared Sep 20, 2001
INSIGHT MILLENNIUM PLUS
K011964
Fasstech
Neurology · 87d
Cleared Sep 06, 2001
BIOREHAB SYSTEM
K011823
Nicolet Biomedical, Inc.
Neurology · 87d
Cleared Aug 30, 2001
INSIGHT GENESIS
K011983
Fasstech
Neurology · 65d
Cleared Jan 04, 2001
REGAIN DESKTOP
K003127
Srs Medical Systems, Inc.
Neurology · 90d

About Product Code HCC - Regulatory Context

510(k) Submission Activity

173 total 510(k) submissions under product code HCC since 1976, with 173 receiving FDA clearance (average review time: 177 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - HCC Product Code

Recent submissions under HCC have taken an average of 268 days to reach a decision - up from 176 days historically. Manufacturers should account for longer review timelines in current project planning.

HCC devices are reviewed by the Neurology panel. Browse all Neurology devices →