Natus Medical, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Natus Medical, Inc.” (first 1995, latest 2010), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 132 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | 4 | 4 |
| GWF | Stimulator, Electrical, Evoked Response | 2 | 2 |
| LBI | Unit, Neonatal Phototherapy | 2 | 2 |
| EWE | Protector, Hearing (Circumaural) | 1 | 1 |
| GHS | Assay, Carboxyhemoglobin | 1 | 1 |
| OMA | Amplitude-Integrated Electroencephalograph | 1 | 1 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 1 | 1 |
Review panels
- Neurology (8)
- General Hospital (2)
- Ear, Nose and Throat (1)
- Hematology (1)
Most recent Natus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093304 | PROTEKTOR 32 | GWF | 2010-08-11 | 294 |
| K093949 | OLYMPIC BRAINZ MONITOR MODEL OBM70001 | OMA | 2010-06-16 | 175 |
| K090019 | NATUS NEUROWORKS, MODEL 104196 | OMB | 2010-02-22 | 416 |
| K083371 | NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) | GWF | 2009-12-08 | 389 |
| K073665 | ALGO 5 NEWBORN HEARING SCREENER | GWJ | 2008-01-25 | 30 |
| K051869 | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM | LBI | 2005-10-07 | 88 |
| K030823 | ALGO 3I NEWBORN HEARING SCREENER | GWJ | 2003-04-09 | 26 |
| K022196 | NATUS BLUE LIGHT PHOTOTHERAPY UNIT | LBI | 2002-09-19 | 76 |
| K013137 | ALGO 3 NEWBORN HEARING SCREENER | GWJ | 2001-10-16 | 27 |
| K974805 | CO-STAT(TM) END TIDAL BREATH ANALYZER | GHS | 1998-03-11 | 78 |
2 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2010-06-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (12 510(k)s)
- Natus Medical Incorporated (10 510(k)s)
- Natus Neurology Incorporated (5 510(k)s)
- Natus Manufacturing Limited (4 510(k)s)
- Natus Medical Denmark Aps (1 510(k)s)
- Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) (1 510(k)s)
- Natus Nicolet Ireland, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Natus Medical, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Natus Medical, Inc.” (first 1995, latest 2010), across 7 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Natus Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Natus Medical, Inc. is 132 days.
Which FDA product codes appear under Natus Medical, Inc.?
The most frequent FDA product codes under this applicant name are GWJ (Stimulator, Auditory, Evoked Response, 4); GWF (Stimulator, Electrical, Evoked Response, 2); LBI (Unit, Neonatal Phototherapy, 2).
Next steps
- See all 12 Natus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWJ, Natus Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.