Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Physiometrix, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
221 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051874 | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG E | Physiometrix, Inc. | 2005-09-02 | 53 | 0 |
| K033999 | SEDLINE WITH FRONTAL PSI | Physiometrix, Inc. | 2004-02-06 | 44 | 0 |
| K020670 | MODEL 4310 PSARRAY2 EEG ELECTRODE | Physiometrix, Inc. | 2002-10-08 | 221 | 0 |
| K020671 | PSA4000 EEG MONITOR WITH FRONTAL PSI | Physiometrix, Inc. | 2002-10-04 | 217 | 0 |
| K001069 | MODEL 4000 EEG MONITOR WITH PSI (PSA4000) | Physiometrix, Inc. | 2000-06-30 | 88 | 0 |
| K001055 | MODEL 4300 PSARRAY EEG ELECTRODE SET | Physiometrix, Inc. | 2000-05-11 | 38 | 0 |
| K970942 | MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM | Physiometrix, Inc. | 1997-06-02 | 80 | 0 |
| K970694 | MODEL 1700, HYDRO PREP | Physiometrix, Inc. | 1997-05-14 | 78 | 2 |
| K962447 | EQUINOX DIGITAL EEG SYSTEM | Physiometrix, Inc. | 1996-12-12 | 171 | 0 |
| K962157 | MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM | Physiometrix, Inc. | 1996-11-25 | 174 | 0 |
| K961609 | MODEL 1220, OR E-NET (54-62 CM) | Physiometrix, Inc. | 1996-05-10 | 15 | 0 |
| K960885 | MODEL 1240, SMALL E NET | Physiometrix, Inc. | 1996-04-26 | 53 | 0 |
| K960873 | MODEL 1210, MEDIUM E-NET | Physiometrix, Inc. | 1996-04-26 | 53 | 0 |
| K960732 | HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL | Physiometrix, Inc. | 1996-04-15 | 53 | 0 |
| K953449 | MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS | Physiometrix, Inc. | 1995-10-12 | 86 | 0 |
| K946318 | MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(T | Physiometrix, Inc. | 1995-04-24 | 117 | 0 |
| K934505 | TRIGEL MULTIFUNCTION ELECTRODE | Physiometrix, Inc. | 1994-11-22 | 433 | 0 |
| K940219 | TRIGEL- MULTIFUNCTION ELECTRODE | Physiometrix, Inc. | 1994-04-12 | 84 | 0 |
| K935260 | PHYSIOMETRIX CABLE ADAPTER MODIFICATION | Physiometrix, Inc. | 1993-12-23 | 51 | 0 |
| K930080 | E*NET NEUROMONITORING SYSTEM | Physiometrix, Inc. | 1993-10-19 | 285 | 0 |
| K931885 | DRIGEL MULTIFUNCTION ELECTRODE | Physiometrix, Inc. | 1993-09-09 | 147 | 0 |
| K921207 | DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION | Physiometrix, Inc. | 1992-10-13 | 215 | 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