Data / Medical devices / Finland / AirLife Finland Oy
AirLife Finland Oy: FDA-registered device maker in Helsinki Uusimaa, Finland, 21 510(k) clearances
AirLife Finland Oy is registered with the FDA (registration 3010838917) in Helsinki Uusimaa, Finland. It lists 37 device types. The FDA files 21 510(k) clearances under its listings, the newest dated July 30, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3010838917
- Address
- Kuortaneenkatu 2, Helsinki Uusimaa, Finland, FIN-00510
- Owner or operator
- SunMed Group Holdings, LLC dba AirLife (10044795)
- Roles
- Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 29, 2013
- Registered through
- 2027
- Brand names listed
- 8570127 (EOL) Unifilter S (Bulk), 557051200 (EOL) Y-filter Plus Edith 1000, ABSORBENT, CARBON-DIOXIDE, ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE, Adhesive Tape and Bandage, Airlife Infant Skin Temp Probe, Anesthesia breathing circuit kit (adult & pediatric), BEDDING, DISPOSABLE, MEDICAL, Blood Pressure Cuff and more
Devices it lists
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 30, 2026 | K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | CCL | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| August 16, 2021 | K211294 | Multi-Link X2 ECG Cable and Leadwire System | DSA | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| October 9, 2020 | K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires | DSA | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| September 13, 2019 | K191273 | Multi-Link X2 ECG and SpO2 Adapter | DSA | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| April 30, 2018 | K171678 | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable | CCK | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| June 22, 2017 | K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | DSA | Substantially Equivalent | Carefusion 303, Inc. | accessdata.fda.gov |
| January 18, 2017 | K162432 | Multi-Link X2 ECG Cable and Lead Wire System | DSA | Substantially Equivalent | Carefusion 2200, Inc. | accessdata.fda.gov |
| August 11, 2010 | K101660 | ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 | DSA | Substantially Equivalent | Kepler Medtec | accessdata.fda.gov |
| November 19, 2008 | K082851 | MULTLINK CABLE AND LEADWIRE SYSTEM | DSA | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
| September 29, 2006 | K061942 | TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 | FLL | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 18, 2006 | K061918 | FOLEY CATHETERS WITH TEMPERATURE PROBE | EYC | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 20, 2005 | K051873 | DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES | FLL | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 27, 2005 | K050837 | REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE | FLL | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 1, 2005 | K043120 | MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER | CAH | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| February 22, 2005 | K043572 | COMPATIBILITY ECG TRUNK CABLES | DSA | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
| March 15, 2004 | K040286 | ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS | DXQ | Substantially Equivalent | Ethox Corp. | accessdata.fda.gov |
| June 20, 2003 | K031653 | DATEX-OHMEDA HMEF 750 | CAH | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
| August 30, 2002 | K021265 | DATEX-OHMEDA HMEF 500 | CAH | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
| November 1, 1999 | K992323 | DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES | MLD | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| March 16, 1998 | K980582 | MULTI-LINK CABLE AND LEAD WIRE SYSTEMS | DSA | Substantially Equivalent | Marquette Medical Systems, Inc. | accessdata.fda.gov |
| February 11, 1980 | K792669 | COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE | HGP | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Circular (Spiral), Scalp And Applicator
- All makers of Recorder, Paper Chart
- All makers of Continuous Measurement Thermometer
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Electrode, Electrocardiograph
- All makers of Condenser, Heat And Moisture (Artificial Nose)
Updated July 30, 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.