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 880.6150](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6150) → FLG — Cleaner, Ultrasonic, Medical Instrument # FLG · Cleaner, Ultrasonic, Medical Instrument _General Hospital · 21 CFR 880.6150 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG ## Overview - **Product Code:** FLG - **Device Name:** Cleaner, Ultrasonic, Medical Instrument - **Regulation:** [21 CFR 880.6150](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6150) - **Device Class:** 1 - **Review Panel:** [General Hospital](/submissions/HO) ## Identification An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves. ## Classification Rationale Class I. The device, including any solutions intended for use with the device for cleaning and sanitizing the instruments, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. ## Recent Cleared Devices (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K944950](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K944950.md) | KLENZYME | Calgon Corp. | Dec 20, 1994 | SESE | | [K944494](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K944494.md) | ALSA-KLENZ | Calgon Vestal Div. | Oct 19, 1994 | SESE | | [K944033](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K944033.md) | BILL EVANS-KLENZ | Calgon Vestal Div. | Oct 7, 1994 | SESE | | [K941163](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K941163.md) | MON-KLENZ | Calgon Vestal Div. | May 18, 1994 | SESE | | [K940263](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K940263.md) | NPH-KLENZ | Calgon Corp. | May 18, 1994 | SESE | | [K935063](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K935063.md) | INSTRU KLENZ | Calgon Corp. | May 9, 1994 | SESE | | [K934666](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K934666.md) | PDS ULTRACLEAN | Medical Polymers, Inc. | Apr 15, 1994 | SESE | | [K931270](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K931270.md) | SURGICLEAN ENZYMATIC INSTRUMENT CLEANER | Surgicot, Inc. | Apr 13, 1994 | SESE | | [K933149](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K933149.md) | INSTRUMENT DETERGENT CONCENTRATE | Nobelpharma USA, Inc. | Feb 16, 1994 | SESE | | [K884660](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K884660.md) | BIOSONIC ULTRASONIC CLEANING SYSTEM | Whaledent Intl. Div. Ipco | Mar 16, 1989 | SESE | | [K862282](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K862282.md) | RAPIDEX BIOLOGICAL SURFACTANT | Rapidex of London | May 11, 1987 | SESE | | [K861147](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K861147.md) | UCS-2, ULTRASONIC CLEANING SOLUTION | Keymed, Inc. | Jun 23, 1986 | SESE | | [K861592](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K861592.md) | WEC-WASH, CATALOG NO. 850-115 | Palmetto Chemical & Supply Co., Inc. | Jun 17, 1986 | SESE | | [K861590](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K861590.md) | WEC-KLEEN, CATALOG N. 850-102 | Palmetto Chemical & Supply Co., Inc. | Jun 17, 1986 | SESE | | [K861588](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K861588.md) | WECK INSTRUMENT CLEANER, CAT. NO. 850-103 | Palmetto Chemical & Supply Co., Inc. | Jun 17, 1986 | SESE | | [K861587](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K861587.md) | WECK CONCENTRATED LIQUID CLEANER | Palmetto Chemical & Supply Co., Inc. | May 19, 1986 | SESE | | [K852527](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K852527.md) | SATALEC SEPTOSONIC SC 80/SC 120 | Spelna, Inc. | Jan 3, 1986 | SESE | | [K842754](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K842754.md) | CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 | Custom Ultrasonics | Nov 28, 1984 | SESE | | [K771679](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG/K771679.md) | MICROFLATOR | Fisons Corp. | Sep 28, 1977 | SESE | ## Top Applicants - Palmetto Chemical & Supply Co., Inc. — 4 clearances - Calgon Corp. — 3 clearances - Calgon Vestal Div. — 3 clearances - Custom Ultrasonics — 1 clearance - Fisons Corp. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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