Spryson America Inc
Pittsburgh, PA, US
Spryson America Inc appears in FDA device records in Pittsburgh, PA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Spryson America Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Neuro Kinetics, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 4 510(k) clearances for Spryson America Inc between 2009 and 2018. The busiest year on record is 2009, with 1. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System | GWN | Substantially Equivalent | |
| K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | GWN | Substantially Equivalent | |
| K143607 | I-Portal NOTC, VNG and VOG | GWN | Substantially Equivalent | |
| K083603 | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL | GWN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2519945 | 2519945 | Spryson America Inc | 201 N Braddock Ave Ste 301, Pittsburgh, PA 15208 US | 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-2730-2015 | 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 diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device. | The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label. | Class II | Terminated | |
| Z-1795-2015 | 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 vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits. | complaints of system malfunction and unintended, sudden movement at start up. No injuries reported. | Class II | Terminated | |
| Z-0966-2014 | 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. | Class II | Terminated | |
| Z-2253-2009 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain