Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KZM — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
137 daysmedian FDA review time
612 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161716 | TEETHAN 2.0 | Bts S.P.A. | 2016-12-21 | 183 | 0 |
| K130158 | M-SCAN | Bio-Research Associates, Inc. | 2013-07-25 | 183 | 0 |
| K113677 | GRINDCARE MEASURE | Medotech A/S | 2012-04-05 | 113 | 0 |
| K082927 | BIOEMG III | Bio-Research Associates, Inc. | 2009-02-06 | 128 | 0 |
| K043373 | DOLOTENS DENTAL TM 1 | Neuromuscular Technologies, Inc. | 2005-09-02 | 268 | 0 |
| K030869 | BITESTRIP | S.L.P. , Ltd. | 2004-05-14 | 422 | 0 |
| K003176 | BIOEMG II AND BIOJVA | Bio-Research Associates, Inc. | 2001-01-04 | 85 | 0 |
| K003287 | MODEL K7 EVALUATION DEVICE | Myotronics-Noromed, Inc. | 2000-11-06 | 17 | 0 |
| K992694 | MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I | Myotronics-Noromed, Inc. | 1999-09-10 | 29 | 0 |
| K981563 | BIOPAK MEASUREMENT SYSTEM | Bio-Research Associates, Inc. | 1998-09-15 | 137 | 0 |
| K944134 | K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 | Myo-Tronics, Inc. | 1994-12-09 | 107 | 0 |
| K922456 | K6-I DIAGNOSTIC SYSTEM | Myo-Tronics, Inc. | 1994-06-09 | 744 | 0 |
| K921919 | MS-100 MYO-SCANNER OR MS-100 EMG SCANNER | Myo-Tronics, Inc. | 1993-01-07 | 259 | 0 |
| K873947 | BIO-EMG MODEL 800 | Bio-Research Associates, Inc. | 1988-04-27 | 212 | 0 |
| K862121 | E.W.L. P-TENS/H-WAVE | Electronic Waveform Laboratory, Inc. | 1987-06-17 | 379 | 0 |
| K862092 | COMFORTRON | M. D. Supply, Inc. | 1986-10-15 | 135 | 0 |
| K850425 | DENTAL ANESTHESIA APPARATUS | Pain Prevention, Inc. | 1986-10-09 | 612 | 0 |
| K830034 | MODEL EM-2 BIOELECTRIC PROCESSOR | Myo-Tronics Research, Inc. | 1983-02-09 | 33 | 0 |
| K810528 | MODEL EM-IR | Myo-Tronics Research, Inc. | 1981-03-31 | 33 | 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