Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Somanetics Corp. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
232 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093422 | VITAL SYNC MODEL 5000 SERIES | Somanetics Corp. | 2010-04-29 | 177 | 0 |
| K091224 | OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MOD | Somanetics Corp. | 2009-07-09 | 73 | 0 |
| K082327 | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C | Somanetics Corp. | 2009-04-03 | 232 | 0 |
| K080769 | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C | Somanetics Corp. | 2008-05-14 | 57 | 0 |
| K051274 | INVOS SYSTEM | Somanetics Corp. | 2005-11-04 | 171 | 0 |
| K040162 | CORRESTORE PATCH SYSTEM | Somanetics Corp. | 2004-03-16 | 50 | 0 |
| K031586 | CORRESTORE PATCH SYSTEM | Somanetics Corp. | 2003-08-07 | 78 | 0 |
| K011487 | CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, | Somanetics Corp. | 2001-11-21 | 190 | 0 |
| K001842 | ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 | Somanetics Corp. | 2000-09-15 | 88 | 0 |
| K971628 | SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) | Somanetics Corp. | 1997-10-10 | 161 | 0 |
| K960614 | SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) | Somanetics Corp. | 1996-06-05 | 113 | 0 |
| K892217 | CAV SAT OXIMETER MODEL 100 | Somanetics Corp. | 1990-05-18 | 410 | 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