Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6710](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6710) → KMG — Purifier, Water, Ultraviolet, Medical

# KMG · Purifier, Water, Ultraviolet, Medical

_General Hospital · 21 CFR 880.6710 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMG

## Overview

- **Product Code:** KMG
- **Device Name:** Purifier, Water, Ultraviolet, Medical
- **Regulation:** [21 CFR 880.6710](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6710)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

A medical ultraviolet water purifier is a device intended for medical purposes that is used to destroy bacteria in water by exposure to ultraviolet radiation.

## Classification Rationale

Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 880.9.

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K012029](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMG/K012029.md) | REMEDY MODEL 2Z12 | Apollo Corp. | Dec 31, 2001 | SESE |
| [K832288](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMG/K832288.md) | HEMOGLOBINOMETER | Mallinckrodt Critical Care | Sep 1, 1983 | SESE |
| [K831253](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMG/K831253.md) | LANCER HEMOGLOBIN ANALYZER REAGENTS | Sherwood Medical Co. | May 9, 1983 | SESE |
| [K813050](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMG/K813050.md) | AQUANOMICS, #MP4SF | Cooper-Hewitt Electric Co. | Dec 2, 1981 | SESE |
| [K813049](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMG/K813049.md) | AQUANOMICS, #HHU100 | Cooper-Hewitt Electric Co. | Dec 2, 1981 | SESE |
| [K813048](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMG/K813048.md) | AQUANOMICS, #MP2SF | Cooper-Hewitt Electric Co. | Dec 2, 1981 | SESE |
| [K813047](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMG/K813047.md) | AQUANOMICS, MINI 60L | Cooper-Hewitt Electric Co. | Dec 2, 1981 | SESE |
| [K813046](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMG/K813046.md) | AQUANOMICS, #HHU60 | Cooper-Hewitt Electric Co. | Dec 2, 1981 | SESE |
| [K813045](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMG/K813045.md) | AQUANOMICS, #SP36SF | Cooper-Hewitt Electric Co. | Dec 2, 1981 | SESE |

## Top Applicants

- Cooper-Hewitt Electric Co. — 6 clearances
- Apollo Corp. — 1 clearance
- Mallinckrodt Critical Care — 1 clearance
- Sherwood Medical Co. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMG](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMG)

**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