Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5640](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5640) → CCQ — Nebulizer, Medicinal, Non-Ventilatory (Atomizer) # CCQ · Nebulizer, Medicinal, Non-Ventilatory (Atomizer) _Anesthesiology · 21 CFR 868.5640 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ ## Overview - **Product Code:** CCQ - **Device Name:** Nebulizer, Medicinal, Non-Ventilatory (Atomizer) - **Regulation:** [21 CFR 868.5640](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5640) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe. ## 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 § 868.9. ## Recent Cleared Devices (20 of 62) Showing 20 most recent of 62 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K972397](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K972397.md) | EZ SPRAY | Intertex Research, Inc. | Sep 23, 1997 | SESE | | [K964956](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K964956.md) | E-Z SPACER MASK (SMALL) | Airpharma, LLC | Apr 23, 1997 | SESE | | [K961894](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K961894.md) | MDI TUTOR | Mdi Tutor, Inc. | Aug 14, 1996 | SESE | | [K961455](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K961455.md) | MEDSHIELD/AEROCHAMBER | Diemolding Corp. | Jul 25, 1996 | SESE | | [K960593](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K960593.md) | SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 | Aradigm Corp. | May 10, 1996 | SESE | | [K922033](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K922033.md) | SALINE SOLUTION- STERILE | Trinity Laboratories, Inc. | Jul 21, 1992 | SESE | | [K900576](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K900576.md) | MODIFIED AEROCHAMBER WITH MASK | Monaghan Medical Corp. | May 13, 1991 | SESE | | [K900557](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K900557.md) | MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER | Monaghan Medical Corp. | Apr 10, 1991 | SESE | | [K895115](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K895115.md) | FRANK INHALER THERMAL S | Buttner-Frank GmbH | May 18, 1990 | SESE | | [K894215](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K894215.md) | EVOLUTION ULTRASONIC | Medical Industries America, Inc. | Apr 16, 1990 | SESE | | [K894555](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K894555.md) | PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED | Dura Pharmaceuticals, Inc. | Jan 24, 1990 | SESE | | [K896070](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K896070.md) | PFEIFFER METERED DOSAGE SYSTEM | Syva Co. | Jan 17, 1990 | SESE | | [K895592](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K895592.md) | FREEWAY NEBULIZER COMPRESSOR | Lifecare Services, Inc. | Nov 21, 1989 | SESE | | [K894441](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K894441.md) | DEVILBISS MODEL 6610D | Devilbiss Health Care, Inc. | Oct 13, 1989 | SESE | | [K894244](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K894244.md) | DEVILBISS MODEL 8500D AND 8500D-608 | Devilbiss Health Care, Inc. | Oct 6, 1989 | SESE | | [K892117](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K892117.md) | GENTLEHALER(R) | Schering Research | Jun 23, 1989 | SESE | | [K875024](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K875024.md) | DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP | Dey Laboratories, Inc. | Jan 22, 1988 | SESE | | [K875011](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K875011.md) | DEY-PAK PURIFIED WATER, USP, STERILE | Dey Laboratories, Inc. | Jan 22, 1988 | SESE | | [K874513](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K874513.md) | MONAGHAN AEROCHAMBER WITH MASK | Monaghan Medical Corp. | Dec 30, 1987 | SESE | | [K873793](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K873793.md) | INSPIREASE(R), DRUG DELIVERY SYSTEM | Key Pharmaceuticals, Inc. | Oct 13, 1987 | SESE | ## Top Applicants - Armour Pharmaceutical Co. — 5 clearances - Monaghan Medical Corp. — 3 clearances - Vortran Medical Technology 1, Inc. — 3 clearances - Devilbiss Health Care, Inc. — 2 clearances - Dey Laboratories, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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