Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart B — Diagnostic Devices](/submissions/EN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 874.1800](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1800) → KHH — Stimulator, Caloric-Air

# KHH · Stimulator, Caloric-Air

_Ear, Nose, Throat · 21 CFR 874.1800 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH

## Overview

- **Product Code:** KHH
- **Device Name:** Stimulator, Caloric-Air
- **Regulation:** [21 CFR 874.1800](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1800)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

An air or water caloric stimulator is a device that delivers a stream of air or water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produce involuntary eye movements that are measured and recorded by a nystagmograph.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K950785](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH/K950785.md) | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | Jedmed Instrument Co. | Jun 28, 1995 | SESE |
| [K946108](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH/K946108.md) | EAR-A-GATOR | Life-Tech Intl., Inc. | Jun 13, 1995 | SESE |
| [K941325](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH/K941325.md) | WATER IRRIGATOR, W1 200 | Strong Medical, Inc. | Aug 9, 1994 | SESE |
| [K931608](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH/K931608.md) | NCA-200 | Ics Medical Corp. | Jun 22, 1993 | SESE |
| [K925237](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH/K925237.md) | AUTOMATIC CALORIC IRRIGATION SYSTEM | Ics Medical Corp. | May 5, 1993 | SESE |
| [K881630](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH/K881630.md) | AUTOMATIC CALORIC IRRIGATION SYSTEM | Ics Medical Corp. | Jun 21, 1988 | SESE |
| [K822179](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH/K822179.md) | FRENZEL EYEGLASSES & RELATED ITEMS | Kelleher Corp. | Sep 21, 1982 | SESE |

## Top Applicants

- Ics Medical Corp. — 3 clearances
- Jedmed Instrument Co. — 1 clearance
- Kelleher Corp. — 1 clearance
- Life-Tech Intl., Inc. — 1 clearance
- Strong Medical, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com