FDA applicant
Natus Medical, Inc.
FDA records 23 decisions for Natus Medical, Inc. (San Carlos, CA) from 1995 to 2018: 22 510(k) clearances and 1 original PMA approval. Most are in product codes LBI (Unit, Neonatal Phototherapy) and GWJ (Stimulator, Auditory, Evoked Response). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 8 of them its own earlier devices. 14 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Natus Medical Incorporated”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Natus Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2018
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Natus Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Natus”
FDA records each applicant name separately; these may or may not be the same firm.