Data / Medical devices / Germany / Stihler Electronic GMBH

Stihler Electronic GMBH: FDA-registered device maker in Leinfelden-Echterdingen Baden-Wurttemberg, Germany, 7 510(k) clearances

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

Stihler Electronic GMBH is registered with the FDA (registration 9617473) in Leinfelden-Echterdingen Baden-Wurttemberg, Germany. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 8, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9617473
FEI number: 3001733054
Address: Gaussstrasse 4, Leinfelden-Echterdingen Baden-Wurttemberg, Germany, 70771
Owner or operator: STIHLER ELECTRONIC GMBH (9036252)
Roles: Complaint file establishment, Manufacturer
First device listed: December 5, 2007
Registered through: 2026
Brand names listed: ASTOPAD Patient Warming System, ASTOTHERM PLUS, ASTOTUBE, ASTOLINE, Astodia, Astoflo Plus, Astoflo Plus ECO, M77432002, M77455502, PRISMAFLO, PRISMAFLO II and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Blood Circuit, Hemodialysis	KOC	2	Manufacturer	accessdata.fda.gov
Surgical Table Cushion	LWG	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Thermal Regulating	DWJ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Transilluminator, Battery-Powered	HJN	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Warmer, Blood, Non-Electromagnetic Radiation	BSB	2	Manufacturer	accessdata.fda.gov
Warmer, Thermal, Infusion Fluid	LGZ	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
July 8, 2026	K260278	ThermAffyx(TM) Patient Safety System	DWJ	Substantially Equivalent	Stihler Electronic GmbH	accessdata.fda.gov
September 4, 2020	K202197	Astopad Patient Warming System	DWJ	Substantially Equivalent	Stihler Electronic GmbH	accessdata.fda.gov
December 19, 2008	K082758	PRISMAFLO II	KOC	Substantially Equivalent	Stihler Electronic GmbH	accessdata.fda.gov
December 18, 2008	K082765	ASTOFLO PLUS	LGZ	Substantially Equivalent	Stihler Electronic GmbH	accessdata.fda.gov
July 24, 2002	K020103	PRISMAFLO	KOC	Substantially Equivalent	Stihler Electronic GmbH	accessdata.fda.gov
September 3, 1999	K991159	PRISMATHERM II, ASTOLINE	BSB	Substantially Equivalent	Stihler Electronic GmbH	accessdata.fda.gov
September 2, 1999	K991160	ASTOTHERM PLUS, ASTOTUBES, ASTOLINE	BSB	Substantially Equivalent	Stihler Electronic 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
September 6, 2018	81755	Class II	Terminated	Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.	PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn	accessdata.fda.gov

Compare with other makers

Updated July 8, 2026. 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.