Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HCC — Predicate Candidate Screening
172 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
364 days90th percentile
172clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233580 | A Breathing System (ABS) | Deepwell Dtx, Inc. | 2024-08-01 | 268 | 0 |
| K222101 | Prism | Graymatters Health , Ltd. | 2023-03-17 | 242 | 0 |
| K180173 | Freespira | Palo Alto Health Sciences, Inc. | 2018-08-23 | 213 | 0 |
| K163448 | GrindCare System | Sunstar Suisse S.A. | 2017-09-01 | 267 | 0 |
| K151050 | Pacifier Activated Lullaby (PAL®) | Power Medical Devices, LLC | 2015-12-22 | 246 | 0 |
| K143507 | NFANT Feeding Solution | Nfant Labs, LLC | 2015-09-09 | 273 | 0 |
| K131586 | CANARY BREATHING SYSTEM | Palo Alto Health Sciences, Inc. | 2013-12-10 | 193 | 0 |
| K122879 | EEGER4 MODEL 4.3 | Eeg Software, LLC | 2013-02-06 | 140 | 0 |
| K111687 | EMG SYSTEM | Myotronics-Noromed, Inc. | 2011-09-29 | 105 | 0 |
| K092675 | GRINDCARE | Medotech A/S | 2010-03-03 | 183 | 0 |
| K073557 | EEG NEUROAMP, MODEL CS10137 | Corscience GmbH & Co. KG | 2008-02-28 | 71 | 1 |
| K071866 | NTRAINER SYSTEM | Kcbiomedix, Inc. | 2008-02-01 | 210 | 0 |
| K071661 | ALPHAONE BIOFEEDBACK SYSTEM | Telediagnostic Systems, Inc. | 2007-09-05 | 78 | 0 |
| K041244 | POLYGRAM NET BIOFEEDBACK APPLICATION | Medtronic Vascular | 2004-08-12 | 93 | 0 |
| K020399 | RESPERATE; MODEL RR-150 | Intercure , Ltd. | 2002-07-02 | 146 | 0 |
| K010388 | SONDREX P.A.L. SYSTEM | Ohmeda Medical | 2001-12-11 | 306 | 0 |
| K013399 | MODEL MES-9000/EMG SYSTEM | Myotronics-Noromed, Inc. | 2001-11-13 | 29 | 0 |
| K012384 | EAR MUFFINS | Bio-Logic Systems Corp. | 2001-10-15 | 80 | 0 |
| K012011 | MODIFICATION TO A620 EEG | Stoelting Co. | 2001-10-10 | 104 | 0 |
| K011964 | INSIGHT MILLENNIUM PLUS | Fasstech | 2001-09-20 | 87 | 0 |
| K011823 | BIOREHAB SYSTEM | Nicolet Biomedical, Inc. | 2001-09-06 | 87 | 0 |
| K011983 | INSIGHT GENESIS | Fasstech | 2001-08-30 | 65 | 0 |
| K003367 | ORION PLATINUM | Srs Medical Systems, Inc. | 2001-01-04 | 66 | 0 |
| K003127 | REGAIN DESKTOP | Srs Medical Systems, Inc. | 2001-01-04 | 90 | 0 |
| K000405 | INTERCURE LTD. RESPI-LOW | Intercure , Ltd. | 2000-05-17 | 100 | 0 |
| K993654 | NEUROCOMP | Neurocybernetics | 2000-01-27 | 90 | 0 |
| K992439 | NORODYN 8000 SEMG SYSTEM, ND-8000 | Myotronics-Noromed, Inc. | 1999-08-13 | 22 | 0 |
| K990778 | INSIGHT MILLENNIUM | Fasstech | 1999-06-03 | 86 | 0 |
| K990538 | BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE | Brainmaster | 1999-05-19 | 89 | 0 |
| K990356 | THE BAGNOLI-8 EMG SYSTEM | Delsys, Inc. | 1999-04-29 | 83 | 0 |
| K983550 | XYZ SYSTEM | Bio-Monitoring International Corp. | 1999-01-07 | 90 | 0 |
| K981934 | THE BAGNOLI-4 EMG SYSTEM | Delsys, Inc. | 1998-08-31 | 90 | 0 |
| K981844 | SLEEP MANAGEMENT SYSTEM | Rmp, Inc. | 1998-08-07 | 73 | 0 |
| K980373 | ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE | Ultramind International , Ltd. | 1998-04-29 | 89 | 0 |
| K971400 | MUSCLE RESPONSE MONITOR | Enriching Your Life | 1998-04-14 | 364 | 0 |
| K971708 | PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE | J & J Engineering, Inc. | 1998-02-18 | 286 | 0 |
| K973537 | PATHWAY ELECTROMYOGRAPH | The Prometheus Group | 1997-12-17 | 90 | 0 |
| K972723 | BIO TROL | Mindmedia Labs, Inc. | 1997-10-02 | 73 | 0 |
| K972487 | EMG RETRAINER | Chattanooga Group, Inc. | 1997-09-26 | 86 | 0 |
| K970051 | MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE | Smith and Nephew Donjoy, Inc. | 1997-07-10 | 184 | 0 |
| K943535 | MODEL ME 300 MUSCLE TESTER | Regulatory Strategies, Inc. | 1997-06-25 | 1070 | 0 |
| K963202 | MEGA ME 3000 PROFESSIONAL MUSCLE TESTER | Mega Electronics , Ltd. | 1997-05-19 | 277 | 0 |
| K965006 | AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) | Stoelting Co. | 1997-02-05 | 51 | 0 |
| K961645 | MRS-2D | Lexicor Medical Technology, Inc. | 1996-10-31 | 185 | 0 |
| K961718 | DEI MODEL 20 EEG | Discovery Engineering Intl., Inc. | 1996-08-27 | 117 | 0 |
| K960761 | PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 | The Prometheus Group | 1996-08-07 | 163 | 0 |
| K954737 | SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE | J-Tech, Inc. | 1996-07-03 | 261 | 0 |
| K960762 | SYNERGY PLUS | The Prometheus Group | 1996-06-13 | 108 | 0 |
| K952797 | AT53 DUAL CHANNEL EMG | Stoelting Co. | 1996-04-17 | 303 | 0 |
| K924313 | DIGITAL CONDUCTANCE METER | The Jayms Co. | 1996-03-14 | 1296 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda