Path: FDA-registered device maker in Germering Bavaria, Germany, 5 510(k) clearances

Name: Path FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Path is registered with the FDA (registration 3008111228) in Germering Bavaria, Germany. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 3, 2022. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008111228
Address: Landsberger Strasse 65, Germering Bavaria, Germany, 82110
Owner or operator: PATH (10042983)
Roles: Manufacturer
First device listed: January 17, 2013
Registered through: 2026
Brand names listed: 1077 EARTIP 12-16 BLUE, 1077 EARTIP 5MM BLUE, 1077 EARTIP 8-11 TRANS 50 PCS, 1077 EARTIP 9-13 FOAM, 1077 PROBE TIP 10 PCS, 1077, ABR ELECTRODE CABLE, 1077, ALPHA DPOAE PROBE, 1077, DPOAE/TEOAE PROBE and more

Devices it lists

Device	Product code	Class	Role	Source
Audiometer	EWO	2	Manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Manufacturer	accessdata.fda.gov
Cushion, Earphone (For Audiometric Testing)	ETT	1	Manufacturer	accessdata.fda.gov
Stimulator, Auditory, Evoked Response	GWJ	2	Manufacturer	accessdata.fda.gov
Tester, Auditory Impedance	ETY	2	Manufacturer	accessdata.fda.gov
Tympanometer, Exempt	PTP	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 3, 2022	K220139	QScreen	GWJ	Substantially Equivalent	Path Medical GmbH	accessdata.fda.gov
October 14, 2021	K211147	ALGO 7i	GWJ	Substantially Equivalent	Path Medical GmbH	accessdata.fda.gov
June 9, 2014	K133012	SENTIERO	EWO	Substantially Equivalent	Path Medical GmbH	accessdata.fda.gov
June 27, 2013	K131141	EARPROBE	GWJ	Substantially Equivalent	Path Medical GmbH	accessdata.fda.gov
July 1, 2010	K100661	EARPROBE	GWJ	Substantially Equivalent	Path Medical GmbH	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 6, 2025	97894	Class II	Ongoing	MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)	Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.	accessdata.fda.gov
September 26, 2023	93275	Class II	Ongoing	SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098	Affected lots of product may experience technical distortions to a greater extent than expected.	accessdata.fda.gov

Compare with other makers

Updated December 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.