# K061443: Smart Usblite, Model M011120

- Pathway: 510(k) (Special)
- Applicant: Intelligent Hearing Systems
- Decided: Jun 23, 2006 after 30 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930328 (1993). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904926: Smart-EP, Intelligent Hearing Systems (1991) Summary page 1.
- K925648: Smart-Screener (Auditory), Intelligent Hearing Systems (1993) Summary page 1.
- K964426: Smartoae, Intelligent Hearing Systems (1997) Summary page 1.
- K023859: Smarttroae, Intelligent Hearing Systems (2003) Summary page 1.
- K031051: Smartep-Assr, Model M811007, Intelligent Hearing Systems (2004) Summary page 1.
- K052060: Opti-Amp DC-Powered, Intelligent Hearing Systems (2005) Summary page 1.

## Most influential descendants
- K193033: GSI Audera Pro (2020), 0 descendants of its own

## Indications for use
The intended use of the Smart USBLifte device system is for the recording of auditory evoked potential, otoacoustic emissions, & auditory steady-state evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders, as an objective measure of cochlear function, and as an adjunctive tool in the estimation of behavioral hearing thresholds on patients of all ages. The Smart USBLite system combines the following FDA 510(k) previously cleared devices into a repackaged, smaller-sized, single, integrated unit: SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and Opti-Amp DC-Powered (K052060). The Smart USBLite is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist’s office or other appropriate setting. The anatomical sites of contact are: (1) The patient’s scalp and possibly other body sites with the contact objects being electrodes that are capable of measuring bio-potentials (2) The patient’s ear with the contact object being a sound delivery device eartip, headphone, ear probe, or ear cups.

Source page: https://510kreport.com/device/K061443
Methodology: https://510kreport.com/methodology