Protektor 32: FDA 510(k) K093304, Natus Medical, Inc.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK093304	Date11 Aug 2010Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K093304

Recalls

1 recall · FDA

- Terminated Z-1067-2015 FDA Class II initiated 2 Jan 2015 on shared 510(k) K093304
Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

2 dated events

11 Aug 2010 Cleared FDA 510(k) K093304
2 Jan 2015 Recall initiated FDA recalls Z-1067-2015

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K093304
FDA product code: GWF

Device class: Class II
Regulation: 21 CFR Part 882.1870
Advisory committee: Neurology
FDA decision: SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Neuro-IOM system with Neuro-IOM.NET software K190703 22 May 2021 FDA record · FDA summary
Cascade IOMAX Intraoperative Monitor K162199 2 Mar 2017 FDA record · FDA summary
Epad K132616 24 Jan 2014 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K093304

52 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K093304
		UDI-DI	Size and differences
Natus 002494 XLTEK	002494	00382830020787	—	On the market
Natus 002495 XLTEK	002495	00382830001267	—	On the market
Natus 002495 XLTEK	002495	00382830020794	—	On the market
Natus 002496 XLTEK	002496	00382830002356	—	On the market
Natus 002498 XLTEK	002498	00382830020862	—	On the market
Natus 002499 XLTEK	002499	00382830002387	—	On the market
Natus 002500 XLTEK	002500	00382830020886	—	On the market
Natus 002501 XLTEK	002501	00382830002394	—	On the market
Natus 002506 Natus Neurology Incorporated	002506	00382830020824	—	On the market
Natus 002507 XLTEK	002507	00382830020831	—	On the market
Natus 002508 XLTEK	002508	00382830020848	—	On the market
Natus 002510 XLTEK	002510	00382830020909	—	On the market
Natus 002511 XLTEK	002511	00382830020916	—	On the market
Natus 002512 XLTEK	002512	00382830020923	—	On the market
Natus 002513 XLTEK	002513	00382830020756	—	On the market
Natus 002514 XLTEK	002514	00382830020770	—	On the market
Natus 002978 XLTEK	002978	00382830010955	—	On the market
Natus 002979 XLTEK	002979	00382830010962	—	On the market
Natus 002980 XLTEK	002980	00382830010979	—	On the market
Natus 003708 XLTEK	003708	00382830020763	—	On the market
Natus 005030 XLTEK	005030	00382830010986	—	On the market
Natus 005031 XLTEK	005031	00382830002714	—	On the market
Natus 005032 XLTEK	005032	00382830011259	—	On the market
Natus 005033 XLTEK	005033	00382830011006	—	On the market
Natus 005562 XLTEK	005562	00382830011013	—	On the market
Natus 010384 XLTEK	010384	00382830015967	—	On the market
Xltek 017846 XLTEK	017846 / 017846	00382830046329	—	On the market
Xltek 017847 XLTEK	017847 / 017847	00382830046336	—	On the market
Xltek 017848 XLTEK	017848 / 017848	00382830046343	—	On the market
Xltek 017849 XLTEK	017849 / 017849	00382830046350	—	On the market
Xltek 017851 XLTEK	017851 / 017851	00382830043847	—	On the market
Xltek 017852 XLTEK	017852 / 017852	00382830043854	—	On the market
Xltek 017853 XLTEK	017853 / 017853	00382830043861	—	On the market
Xltek 017854 XLTEK	017854 / 017854	00382830043878	—	On the market
Xltek 017866 XLTEK	017866 / 017866	00382830046169	—	On the market
Xltek 017867 XLTEK	017867 / 017867	00382830046176	—	On the market
XLTEK 017868 XLTEK	017868	00382830048651	—	On the market
Xltek 017869 XLTEK	017869 / 017869	00382830046190	—	On the market
Xltek 017870 XLTEK	017870 / 017870	00382830046206	—	On the market
Xltek 017871 XLTEK	017871 / 017871	00382830046213	—	On the market
Xltek 017872 XLTEK	017872 / 017872	00382830046220	—	On the market
Xltek 017873 XLTEK	017873 / 017873	00382830046237	—	On the market
Xltek 017878 XLTEK	017878 / 017878	00382830046244	—	On the market
Xltek 017879 XLTEK	017879 / 017879	00382830046251	—	On the market
Xltek 017880 XLTEK	017880 / 017880	00382830046268	—	On the market
Xltek 017881 XLTEK	017881 / 017881	00382830046275	—	On the market
Xltek 017882 XLTEK	017882 / 017882	00382830046282	—	On the market
Xltek 017883 XLTEK	017883 / 017883	00382830046299	—	On the market
Xltek 017884 XLTEK	017884 / 017884	00382830046305	—	On the market
Xltek 017885 XLTEK	017885 / 017885	00382830046312	—	On the market

Similar devices

Other devices filed under FDA product code GWF (Stimulator, Electrical, Evoked Response).

Other devices from Natus Medical, Inc.

Natus Blue Light Phototherapy Unit LBI

Class II
Olympic Brainz Monitor Model OBM70001

Class II
Algo 3 Newborn Hearing Screener

Class II
Algo 3I Newborn Hearing Screener

Class II

See all devices from Natus Medical, Inc. →

Regulatory status

Recalls

Timeline

Coverage

Specification

Related clearances

Cited by

Devices cleared under K093304

Similar devices

Other devices from Natus Medical, Inc.

Natus Blue Light Phototherapy Unit LBI

Olympic Brainz Monitor Model OBM70001

Algo 3 Newborn Hearing Screener

Algo 3I Newborn Hearing Screener