Company · US
Natus Medical Incorporated
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2018. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
22recalls (1 in 12 months)
18recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LBI | Unit, Neonatal Phototherapy | 14 |
| GWJ | Stimulator, Auditory, Evoked Response | 6 |
| GWF | Stimulator, Electrical, Evoked Response | 3 |
| EWO | Audiometer | 2 |
| FMZ | Incubator, Neonatal | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 |
| JXG | Shunt, Central Nervous System And Components | 2 |
| MXM | Cap, Cooling (Infants) | 2 |
| ETY | Tester, Auditory Impedance | 1 |
| EWE | Protector, Hearing (Circumaural) | 1 |
| GHS | Assay, Carboxyhemoglobin | 1 |
| GWE | Stimulator, Photic, Evoked Response | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 |
| LDS | Device, Pasteurization, Hot Water | 1 |
| MEC | Disinfector, Medical Devices | 1 |
| MNR | Ventilatory Effort Recorder | 1 |
| OMA | Amplitude-Integrated Electroencephalograph | 1 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 1 |
| PSP | Intracranial Pressure & Temperature Monitoring Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 13, 2018 | K182178 | neoBLUE blanket LED Phototherapy System Natus Medical Incorporated | LBI |
| Sep 7, 2018 | K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable Natus Medical Incorporated | HKI |
| Dec 12, 2016 | K160745 | neoBLUE compact LED Phototherapy System Natus Medical Incorporated | LBI |
| May 27, 2016 | K160305 | neoBLUE® LED Phototherapy System Natus Medical Incorporated | LBI |
| Apr 20, 2015 | K143440 | Natus Quantum Natus Medical Incorporated, CA | GWQ |
| Aug 22, 2014 | K141446 | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, Natus Medical Incorporated | GWJ |
| Apr 2, 2012 | K112247 | A BAER WITH ABAER I/O FUNCTION Natus Medical Incorporated | EWO |
| Dec 28, 2011 | K111618 | AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION Natus Medical Incorporated | EWO |
| May 13, 2011 | K103589 | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM Natus Medical Incorporated | LBI |
| Aug 11, 2010 | K093304 | PROTEKTOR 32 Natus Medical, Inc., CA | GWF |
| Jun 16, 2010 | K093949 | OLYMPIC BRAINZ MONITOR MODEL OBM70001 Natus Medical, Inc., CA | OMA |
| Apr 9, 2010 | K100683 | NEUROLINK IP MODEL: PK1117 Natus Medical Incorporated, CA | GWQ |
| Feb 22, 2010 | K090019 | NATUS NEUROWORKS, MODEL 104196 Natus Medical, Inc., CA | OMB |
| Dec 8, 2009 | K083371 | NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) Natus Medical, Inc. | GWF |
| Jan 25, 2008 | K073665 | ALGO 5 NEWBORN HEARING SCREENER Natus Medical, Inc. | GWJ |
| Oct 7, 2005 | K051869 | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM Natus Medical, Inc. | LBI |
| Apr 9, 2003 | K030823 | ALGO 3I NEWBORN HEARING SCREENER Natus Medical, Inc. | GWJ |
| Sep 19, 2002 | K022196 | NATUS BLUE LIGHT PHOTOTHERAPY UNIT Natus Medical, Inc. | LBI |
| Oct 16, 2001 | K013137 | ALGO 3 NEWBORN HEARING SCREENER Natus Medical, Inc. | GWJ |
| Mar 11, 1998 | K974805 | CO-STAT(TM) END TIDAL BREATH ANALYZER Natus Medical, Inc. | GHS |
| Feb 9, 1995 | K935160 | MINIMUFFS Natus Medical, Inc. | EWE |
| Jan 5, 1995 | K936039 | ALGO-2 NEWBORN HEARING SCREENER Natus Medical, Inc. | GWJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2026 | NATUS MEDICAL INCORPORATED Embletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011 Open, Classified |
MNR | K122516 |
| Jan 4, 2024 | Natus Medical Incorporated EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only Open, Classified |
JXG | K162437 |
| Jan 4, 2024 | Natus Medical Incorporated External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only Open, Classified |
JXG | K162437 |
| Dec 20, 2022 | Natus Medical Incorporated The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedure Open, Classified |
PSP | None listed |
| Jun 2, 2017 | Natus Medical Incorporated The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and vir Terminated |
MEC | K081094 |
| Apr 14, 2017 | Natus Medical Incorporated Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680.
Produc Terminated |
LBI | K022196 |
| Dec 15, 2016 | Natus Medical Incorporated Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Terminated |
LBI | K103589 |
| Oct 28, 2016 | Natus Medical Incorporated Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia.
006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad Terminated |
LBI | K103589 |
| Oct 7, 2016 | Natus Medical Incorporated The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator.
Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007. Terminated |
FMZ | K070291 |
| Jun 1, 2016 | Natus Medical Incorporated Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01. Terminated |
LDS | None listed |
| Apr 11, 2016 | Natus Medical Incorporated Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066.
Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680.
Product Usage:
Used to provide tre Terminated |
LBI | K022196 |
| Apr 11, 2016 | Natus Medical Incorporated Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator. Terminated |
FMZ | K070291 |
| Oct 21, 2015 | Natus Medical Incorporated Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103 Terminated |
LBI | K022196 |
| Apr 10, 2015 | Natus Medical Incorporated Natus neoBLUE blanket LED Phototherapy system which includes the following items:
006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad
006254 neoBLUE blanket LED Light Box
006895 Terminated |
LBI | K103589 |
| Feb 9, 2015 | Natus Medical Incorporated EPWorks software used in the Xltek Protektor Stimulator
Product Usage:
Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, s Terminated |
GWF | K040358 |
| Feb 9, 2015 | Natus Medical Incorporated EPWorks software used in the Protektor 32
Product Usage:
Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation Terminated |
GWE | K093304 |
| Dec 22, 2014 | Natus Medical Incorporated Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy. Terminated |
LBI | K022196 |
| Nov 30, 2012 | Natus Medical Incorporated The product has the Catalogue/Part number 60010.
Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is Terminated |
MXM | None listed |
| Jun 20, 2012 | Natus Medical Incorporated Olympic Cool-Cap System is intended to provide treatment for
neonatal hypoxic-ischemic encephalopathy (HIE).
The Cool-Cap is indicated for use in full term infants (more than 36 week gestational ag Terminated |
MXM | None listed |
| Aug 3, 2010 | Natus Medical Inc SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154 Terminated |
GWJ | K952080 |
| Nov 24, 2009 | Natus Medical Incorporated The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System" Terminated |
LBI | K022196 |
| Jul 13, 2005 | Natus Medical Inc Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing S Terminated |
ETY | K013137 K030823 +2 |