Data / Medical devices / United States / Spryson America Inc
Spryson America Inc: FDA-registered device maker in Pittsburgh, PA, United States, 5 510(k) clearances
Spryson America Inc is registered with the FDA (registration 2519945) in Pittsburgh, PA, United States. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated November 29, 2019. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2519945
- Address
- 201 N Braddock Ave Ste 301, Pittsburgh, PA, United States, 15208
- Owner or operator
- Spryson America Inc (10090068)
- Roles
- Manufacturer
- First device listed
- February 9, 2024
- Registered through
- 2026
- Brand names listed
- Neurolign Dx, Neurolign Dx Falcon, Spryson Dx 200, Spryson Dx Falcon, Spryson NOTC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nystagmograph | GWN | 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 |
|---|---|---|---|---|---|---|
| November 29, 2019 | K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph | GWN | Substantially Equivalent | Neurolign USA, LLC | accessdata.fda.gov |
| July 24, 2018 | K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System | GWN | Substantially Equivalent | Neuro Kinetics, Inc. | accessdata.fda.gov |
| November 22, 2017 | K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | GWN | Substantially Equivalent | Neuro Kinetics, Inc. | accessdata.fda.gov |
| July 8, 2015 | K143607 | I-Portal NOTC, VNG and VOG | GWN | Substantially Equivalent | Neuro Kinetics, Inc. | accessdata.fda.gov |
| August 6, 2009 | K083603 | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL | GWN | Substantially Equivalent | Neuro Kinetics | 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 21, 2015 | 71832 | Class II | Terminated | Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnosti | The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label. | accessdata.fda.gov |
| April 30, 2015 | 71264 | Class II | Terminated | I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of | complaints of system malfunction and unintended, sudden movement at start up. No injuries reported. | accessdata.fda.gov |
| November 21, 2013 | 66995 | Class II | Terminated | Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball. | The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process. | accessdata.fda.gov |
| July 24, 2009 | 52961 | Not yet classified | Terminated | VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing. | Marketed without a 510k or PMA submission to include the normative data display. | accessdata.fda.gov |
Compare with other makers
Updated November 29, 2019. 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.