Natus Medical Incorporated: FDA clearances and approvals
Natus Medical Incorporated has 10 FDA 510(k) clearances (first 2010, latest 2018), plus 1 PMA decision, across 6 product codes in 4 review panels. Median 510(k) review time: 130 days. openFDA lists 19 product recalls by a recalling firm named Natus Medical Incorporated.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 242 |
| 2013 | 0 | — |
| 2014 | 1 | 81 |
| 2015 | 1 | 139 |
| 2016 | 2 | 191 |
| 2017 | 0 | — |
| 2018 | 2 | 70 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Natus Medical Incorporated's cleared 510(k)s took a median 70 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 160 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | 4 | 4 |
| EWO | Audiometer | 2 | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
| MXM | Cap, Cooling (Infants) | 1 | 0 |
Review panels
- General Hospital (4)
- Neurology (4)
- Ear, Nose and Throat (2)
- Ophthalmic (1)
Most recent Natus Medical Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182178 | neoBLUE blanket LED Phototherapy System | LBI | 2018-12-13 | 122 |
| K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable | HKI | 2018-09-07 | 17 |
| K160745 | neoBLUE compact LED Phototherapy System | LBI | 2016-12-12 | 269 |
| K160305 | neoBLUE® LED Phototherapy System | LBI | 2016-05-27 | 113 |
| K143440 | Natus Quantum | GWQ | 2015-04-20 | 139 |
| K141446 | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, | GWJ | 2014-08-22 | 81 |
| K112247 | A BAER WITH ABAER I/O FUNCTION | EWO | 2012-04-02 | 242 |
| K111618 | AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION | EWO | 2011-12-28 | 201 |
| K103589 | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM | LBI | 2011-05-13 | 157 |
| K100683 | NEUROLINK IP MODEL: PK1117 | GWQ | 2010-04-09 | 30 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P040025 | PMA | OLYMPIC COOL-CAP | 2006-12-20 |
Recalls
19 product recalls in 17 recall events; 3 initiated in the last five years. Most recent: 2023-11-28.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Natus Medical Incorporated have?
Natus Medical Incorporated has 10 FDA 510(k) clearances (first 2010, latest 2018), plus 1 PMA decision, across 6 product codes in 4 review panels.
How long does FDA take to clear Natus Medical Incorporated's 510(k)s?
The median time from FDA receipt to decision across Natus Medical Incorporated's cleared 510(k)s is 130 days.
What devices does Natus Medical Incorporated make?
Its most frequent FDA product codes are LBI (Unit, Neonatal Phototherapy, 4); EWO (Audiometer, 2); GWQ (Full-Montage Standard Electroencephalograph, 2).
Has Natus Medical Incorporated had device recalls?
openFDA lists 19 product recalls in 17 recall events by a recalling firm whose name matches Natus Medical Incorporated; the most recent began 2023-11-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 Natus Medical Incorporated clearances with predicates and recalls
- Run predicate analysis for product code LBI, Natus Medical Incorporated's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.