Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Natus Medical, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
175 daysmedian FDA review time
416 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093304 | PROTEKTOR 32 | Natus Medical, Inc. | 2010-08-11 | 294 | 1 |
| K093949 | OLYMPIC BRAINZ MONITOR MODEL OBM70001 | Natus Medical, Inc. | 2010-06-16 | 175 | 0 |
| K090019 | NATUS NEUROWORKS, MODEL 104196 | Natus Medical, Inc. | 2010-02-22 | 416 | 0 |
| K083371 | NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) | Natus Medical, Inc. | 2009-12-08 | 389 | 0 |
| K073665 | ALGO 5 NEWBORN HEARING SCREENER | Natus Medical, Inc. | 2008-01-25 | 30 | 0 |
| K051869 | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM | Natus Medical, Inc. | 2005-10-07 | 88 | 0 |
| K030823 | ALGO 3I NEWBORN HEARING SCREENER | Natus Medical, Inc. | 2003-04-09 | 26 | 1 |
| K022196 | NATUS BLUE LIGHT PHOTOTHERAPY UNIT | Natus Medical, Inc. | 2002-09-19 | 76 | 4 |
| K013137 | ALGO 3 NEWBORN HEARING SCREENER | Natus Medical, Inc. | 2001-10-16 | 27 | 1 |
| K974805 | CO-STAT(TM) END TIDAL BREATH ANALYZER | Natus Medical, Inc. | 1998-03-11 | 78 | 0 |
| K935160 | MINIMUFFS | Natus Medical, Inc. | 1995-02-09 | 468 | 0 |
| K936039 | ALGO-2 NEWBORN HEARING SCREENER | Natus Medical, Inc. | 1995-01-05 | 381 | 1 |
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