Neuro Kinetics, Inc.

FDA recalling firm · 3 enforcement events · 3 product records · 2013–2015 · PA

Neuro Kinetics, Inc. has 3 FDA enforcement events on this register (3 product records) between 2013 and 2015: 3 device; the busiest year was 2015 with 2.

0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in PA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
21 Jul 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…	Device	Class II	1	Terminated
30 Apr 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…	Device	Class II	1	Terminated
21 Nov 2013	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.	Device	Class II	1	Terminated

By type and class

Device3

Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Neuro Kinetics, Inc. by year initiated.

Questions and answers

How many FDA recalls has Neuro Kinetics, Inc. had?

3 enforcement events (3 product records) on this register, 2013–2015: 3 device.

Are any Neuro Kinetics, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Neuro Kinetics, Inc. recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.