Data / Medical devices / Finland / Innokas Medical OY
Innokas Medical OY: FDA-registered device maker in KEMPELE Pohjois-Pohjanmaa, Finland, 1 510(k) clearance
Innokas Medical OY is registered with the FDA (registration 3007615597) in KEMPELE Pohjois-Pohjanmaa, Finland. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 30, 2014. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007615597
- Address
- Vihikari 10, KEMPELE Pohjois-Pohjanmaa, Finland, 90440
- Owner or operator
- Innokas Yhtyma Oy (10026175)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer
- First device listed
- August 17, 2011
- Registered through
- 2026
- Brand names listed
- CYPRA HIT1, HIT3 HIT5, HIT6, HITM, HITSD, SMARTPHANTOM CT, SMARTPHANTOM RT, STATICPHANTOM, Catalyst+; Catalyst+ HD; Catalyst+ HD Ring Gantry; Catalyst+ PT; Catalyst+ PT X4, Keikku, LymphaTouch, PhysioTouch, Sentinel 4DCT, VC150
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Contract manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Contract manufacturer | accessdata.fda.gov |
| Monitor, Patient Position, Light-Beam | IWE | 1 | Contract manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Stethoscope, Electronic | DQD | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| October 30, 2014 | K133810 | VC150 VITAL SIGNS MONITOR | MWI | Substantially Equivalent | Innokas Yhtyma | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 27, 2016 | 74884 | Class II | Terminated | CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care. | A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements. | accessdata.fda.gov |
| October 22, 2015 | 72475 | Class II | Terminated | CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans | Monitor may shut down unintentionally without restarting. | accessdata.fda.gov |
| December 3, 2014 | 70068 | Class II | Terminated | VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014. | If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Accelerator, Linear, Medical
- All makers of Monitor, Patient Position, Light-Beam
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Stethoscope, Electronic
Updated August 19, 2016. 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.