Stihler Electronic GmbH
Leinfelden-Echterdingen Baden-Wurttemberg, DE
STIHLER ELECTRONIC GMBH appears in FDA device records in Leinfelden-Echterdingen Baden-Wurttemberg, DE. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Stihler Electronic GmbH between 1999 and 2026. The busiest year on record is 1999, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2002 | 1 |
| 2008 | 2 |
| 2020 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260278 | ThermAffyx(TM) Patient Safety System | DWJ | Substantially Equivalent | |
| K202197 | Astopad Patient Warming System | DWJ | Substantially Equivalent | |
| K082758 | PRISMAFLO II | KOC | Substantially Equivalent | |
| K082765 | ASTOFLO PLUS | LGZ | Substantially Equivalent | |
| K020103 | PRISMAFLO | KOC | Substantially Equivalent | |
| K991159 | PRISMATHERM II, ASTOLINE | BSB | Substantially Equivalent | |
| K991160 | ASTOTHERM PLUS, ASTOTUBES, ASTOLINE | BSB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9617473 | 3001733054 | STIHLER ELECTRONIC GMBH | Gaussstrasse 4, Leinfelden-Echterdingen Baden-Wurttemberg 70771 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0761-2019 | Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 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 | Class II | Terminated | |
| Z-0760-2019 | Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 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 | Class II | Terminated | |
| Z-0759-2019 | 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 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain