Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: CCQ FDA class 1

Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Anesthesiology

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The Non-Ventilatory Medicinal Nebulizer (Atomizer) is an anesthesiology device that generates a fine aerosol mist from liquid medications for inhalation by spontaneously breathing patients, not intended for use in-line with mechanical ventilation circuits. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CCQ, regulated under 21 CFR 868.5640, within the Anesthesiology medical specialty. No special flags apply to this device.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K972397

EZ SPRAY

Sep 23, 1997

Substantially Equivalent

INTERTEX RESEARCH, INC.

K964956

E-Z SPACER MASK (SMALL)

Apr 23, 1997

Substantially Equivalent

AIRPHARMA, LLC

K961894

MDI TUTOR

Aug 14, 1996

Substantially Equivalent

MDI TUTOR, INC.

K961455

MEDSHIELD/AEROCHAMBER

Jul 25, 1996

Substantially Equivalent

DIEMOLDING CORP.

K960593

SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100

May 10, 1996

Substantially Equivalent

ARADIGM CORP.

K922033

SALINE SOLUTION- STERILE

Jul 21, 1992

Substantially Equivalent

TRINITY LABORATORIES, INC.

K900576

MODIFIED AEROCHAMBER WITH MASK

May 13, 1991

Substantially Equivalent

MONAGHAN MEDICAL CORP.

K900557

MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER

Apr 10, 1991

Substantially Equivalent

MONAGHAN MEDICAL CORP.

K895115

FRANK INHALER THERMAL S

May 18, 1990

Substantially Equivalent

BUTTNER-FRANK GMBH

K894215

EVOLUTION ULTRASONIC

Apr 16, 1990

Substantially Equivalent

MEDICAL INDUSTRIES AMERICA, INC.

K894555

PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED

Jan 24, 1990

Substantially Equivalent

DURA PHARMACEUTICALS, INC.

K896070

PFEIFFER METERED DOSAGE SYSTEM

Jan 17, 1990

Substantially Equivalent

SYVA CO.

K895592

FREEWAY NEBULIZER COMPRESSOR

Nov 21, 1989

Substantially Equivalent

LIFECARE SERVICES, INC.

K894441

DEVILBISS MODEL 6610D

Oct 13, 1989

Substantially Equivalent

DEVILBISS HEALTH CARE, INC.

K894244

DEVILBISS MODEL 8500D AND 8500D-608

Oct 06, 1989

Substantially Equivalent

DEVILBISS HEALTH CARE, INC.

K892117

GENTLEHALER(R)

Jun 23, 1989

Substantially Equivalent

SCHERING RESEARCH

K875011

DEY-PAK PURIFIED WATER, USP, STERILE

Jan 22, 1988

Substantially Equivalent

DEY LABORATORIES, INC.

K875024

DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP

Jan 22, 1988

Substantially Equivalent

DEY LABORATORIES, INC.

K874513

MONAGHAN AEROCHAMBER WITH MASK

Dec 30, 1987

Substantially Equivalent

MONAGHAN MEDICAL CORP.

K873793

INSPIREASE(R), DRUG DELIVERY SYSTEM

Oct 13, 1987

Substantially Equivalent

KEY PHARMACEUTICALS, INC.

K873477

INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)

Oct 09, 1987

Substantially Equivalent

VORTRAN MEDICAL TECHNOLOGY 1, INC.

K872315

MISTMASTER

Sep 11, 1987

Substantially Equivalent

SONORA RESPIRATORY PRODUCTS, INC.

K871151

THE SPIRA ELEKTRO 2

May 15, 1987

Substantially Equivalent

WARREN E. COLLINS, INC.

K870332

PREFILLED RESPIRATORY THERAPY VIALS

Apr 01, 1987

Substantially Equivalent

AUTOMATIC LIQUID PACKAGING, INC.

K870027

HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER

Mar 16, 1987

Substantially Equivalent

SALTER LABS

K870755

CHALLENGER DOSIMETER

Mar 16, 1987

Substantially Equivalent

SALTER LABS

K860800

ROSENTHAL-FRENCH NEBULIZATION DOSIMETER

Mar 27, 1986

Substantially Equivalent

LABORATORY FOR APPLIED IMMUNOLOGY, INC.

K860875

CIRRUS DRUG NEBULIZER MK III

Mar 20, 1986

Substantially Equivalent

DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.

K854952

CIRRUS NEBULIZER-DELUXE KIT

Jan 28, 1986

Substantially Equivalent

DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.

K854550

MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA

Dec 19, 1985

Substantially Equivalent

MEDIPART JERRY ALEXANDER

K854551

MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S

Dec 19, 1985

Substantially Equivalent

MEDIPART JERRY ALEXANDER

K854520

PULMO-AIDE MODEL 5610D

Dec 09, 1985

Substantially Equivalent

THE DEVILBISS CO.

K852627

MAXI-NEB

Sep 26, 1985

Substantially Equivalent

ASHAI CO. LTD.

K853071

MEDIX ELECTRONIC NEBULIZING SYSTEM

Aug 29, 1985

Substantially Equivalent

MEDIX CORP.

K853350

SYNCHRONER TM (PROPOSED TRADENAME)

Aug 29, 1985

Substantially Equivalent

FISONS CORP.

K851525

PFEIFFER PUMP

Aug 08, 1985

Substantially Equivalent

ING. ERICH PFEIFFER GMBH & CO. KG.

K851254

MICRO-INHALER MODEL TV-7000 & TV-8000

Jun 18, 1985

Substantially Equivalent

BIOCLIMATIC, INC.

K850926

MICRON ONE PORTA. ULTRASONIC NEBULIZER

May 23, 1985

Substantially Equivalent

ENDOTEK DEVELOPMENT LABORATORIES

K844591

MIST-EASE NEBULIZER

Dec 13, 1984

Substantially Equivalent

GENERAL PHYSIOTHERAPY, INC.

K843102

AVA-NEB NEBULIZER

Aug 17, 1984

Substantially Equivalent

AVATRON, INC.

K842988

VMT GENTLE-HALER

Aug 07, 1984

Substantially Equivalent

VORTRAN MEDICAL TECHNOLOGY 1, INC.

K841987

ARM-A-VIAL LV STERIAL WATER FOR INHALA

Jul 27, 1984

Substantially Equivalent

ARMOUR PHARMACEUTICAL CO.

K841990

ARM-A-CARE NEBULIZER-NEBULIZER

Jul 27, 1984

Substantially Equivalent

ARMOUR PHARMACEUTICAL CO.

K841989

ARM-A-VIAL LV SODIUM CHLORIDE INHALAT

Jul 27, 1984

Substantially Equivalent

ARMOUR PHARMACEUTICAL CO.

K841988

ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT

Jul 27, 1984

Substantially Equivalent

ARMOUR PHARMACEUTICAL CO.

K841991

ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS

Jul 27, 1984

Substantially Equivalent

ARMOUR PHARMACEUTICAL CO.

K842192

CROUP TENT FRAME

Jun 25, 1984

Substantially Equivalent

HOME RUN TREADMILL CO.

K841894

VMT HAND HELD NEBULIZER

Jun 05, 1984

Substantially Equivalent

VORTRAN MEDICAL TECHNOLOGY 1, INC.

K841469

MISTY OX DISPOS. NEBULIZER

Apr 24, 1984

Substantially Equivalent

MEDICAL MOLDING CORP. OF AMERICA

K841321

AIR-NEB NEBULIZER COMPRESSOR UNIT

Apr 13, 1984

Substantially Equivalent

AIRMED CORP.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

Commonly searched

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