Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QJQ — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
202 daysmedian FDA review time
672 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252951 | Genesis Sleep | Neurofield, Inc. | 2025-12-31 | 106 | 0 |
| K232253 | Modius Stress | Neurovalens Limited | 2024-03-27 | 243 | 0 |
| K230826 | Modius Sleep | Neurovalens , Ltd. | 2023-10-27 | 217 | 0 |
| K182311 | Cervella | Innovative Neurological Devices, LLC | 2019-03-07 | 195 | 0 |
| K090052 | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C | Johari Digital Healthcare , Ltd. | 2009-05-29 | 142 | 0 |
| K070412 | ELEXOMA MEDIC | Redplane AG | 2008-05-21 | 464 | 0 |
| K062284 | CES ULTRA | Neuro-Fitness, LLC | 2007-04-05 | 241 | 1 |
| K060158 | NET-2000 MICROCURRENT STIMULATOR | Auri-Stem Medical, Inc. | 2006-10-13 | 266 | 0 |
| K024377 | TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 | Kalaco Scientific, Inc. | 2003-07-21 | 202 | 0 |
| K932050 | NH-2002 | New Horizon Health Care | 1995-06-05 | 769 | 0 |
| K903014 | ALPHA-STIM CS | Electromedical Products, Inc. | 1992-05-12 | 672 | 0 |
| K910616 | LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR | Life Balance Intl., Inc. | 1992-05-12 | 455 | 0 |
| K903654 | LISS CRANIAL STIMULATOR MODEL SBL202-B | Medical Consultants Intl. , Ltd. | 1990-10-04 | 90 | 1 |
| K894515 | LISS CRANIAL STIMULATOR MODEL SBL201-M | Medical Consultants Intl. , Ltd. | 1990-05-03 | 288 | 0 |
| K895175 | NF-1 MINDPEACE | Neurofitness | 1989-11-08 | 90 | 0 |
| K894097 | NTI-1000 | Neurotek, Inc. | 1989-09-25 | 108 | 0 |
| K883812 | HP-1 (HEALTHPAX) | Healthdirections, Inc. | 1988-11-28 | 81 | 1 |
| K873920 | BR-2 BIOREST | Biorest, Inc. | 1987-12-29 | 95 | 0 |
| K771534 | BIOTRON 18 | Biotronics Corp. | 1977-08-26 | 16 | 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