Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CCQ — Predicate Candidate Screening
62 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
114 days90th percentile
62clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972397 | EZ SPRAY | Intertex Research, Inc. | 1997-09-23 | 89 | 0 |
| K964956 | E-Z SPACER MASK (SMALL) | Airpharma, LLC | 1997-04-23 | 133 | 0 |
| K961894 | MDI TUTOR | Mdi Tutor, Inc. | 1996-08-14 | 90 | 0 |
| K961455 | MEDSHIELD/AEROCHAMBER | Diemolding Corp. | 1996-07-25 | 100 | 0 |
| K960593 | SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER S | Aradigm Corp. | 1996-05-10 | 88 | 0 |
| K922033 | SALINE SOLUTION- STERILE | Trinity Laboratories, Inc. | 1992-07-21 | 81 | 0 |
| K900576 | MODIFIED AEROCHAMBER WITH MASK | Monaghan Medical Corp. | 1991-05-13 | 460 | 0 |
| K900557 | MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER | Monaghan Medical Corp. | 1991-04-10 | 427 | 0 |
| K895115 | FRANK INHALER THERMAL S | Buttner-Frank GmbH | 1990-05-18 | 276 | 0 |
| K894215 | EVOLUTION ULTRASONIC | Medical Industries America, Inc. | 1990-04-16 | 301 | 0 |
| K894555 | PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED | Dura Pharmaceuticals, Inc. | 1990-01-24 | 188 | 0 |
| K896070 | PFEIFFER METERED DOSAGE SYSTEM | Syva Co. | 1990-01-17 | 90 | 0 |
| K895592 | FREEWAY NEBULIZER COMPRESSOR | Lifecare Services, Inc. | 1989-11-21 | 67 | 0 |
| K894441 | DEVILBISS MODEL 6610D | Devilbiss Health Care, Inc. | 1989-10-13 | 88 | 0 |
| K894244 | DEVILBISS MODEL 8500D AND 8500D-608 | Devilbiss Health Care, Inc. | 1989-10-06 | 107 | 0 |
| K892117 | GENTLEHALER(R) | Schering Research | 1989-06-23 | 84 | 0 |
| K875011 | DEY-PAK PURIFIED WATER, USP, STERILE | Dey Laboratories, Inc. | 1988-01-22 | 49 | 0 |
| K875024 | DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP | Dey Laboratories, Inc. | 1988-01-22 | 49 | 0 |
| K874513 | MONAGHAN AEROCHAMBER WITH MASK | Monaghan Medical Corp. | 1987-12-30 | 58 | 0 |
| K873793 | INSPIREASE(R), DRUG DELIVERY SYSTEM | Key Pharmaceuticals, Inc. | 1987-10-13 | 26 | 0 |
| K873477 | INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN) | Vortran Medical Technology 1, Inc. | 1987-10-09 | 39 | 0 |
| K872315 | MISTMASTER | Sonora Respiratory Products, Inc. | 1987-09-11 | 86 | 0 |
| K871151 | THE SPIRA ELEKTRO 2 | Warren E. Collins, Inc. | 1987-05-15 | 53 | 0 |
| K870332 | PREFILLED RESPIRATORY THERAPY VIALS | Automatic Liquid Packaging, Inc. | 1987-04-01 | 63 | 0 |
| K870027 | HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER | Salter Labs | 1987-03-16 | 70 | 1 |
| K870755 | CHALLENGER DOSIMETER | Salter Labs | 1987-03-16 | 18 | 0 |
| K860800 | ROSENTHAL-FRENCH NEBULIZATION DOSIMETER | Laboratory For Applied Immunology, Inc. | 1986-03-27 | 23 | 0 |
| K860875 | CIRRUS DRUG NEBULIZER MK III | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 | 23 | 0 |
| K854952 | CIRRUS NEBULIZER-DELUXE KIT | Dhd Medical Products Div. Diemolding Corp. | 1986-01-28 | 49 | 0 |
| K854550 | MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA | Medipart Jerry Alexander | 1985-12-19 | 36 | 0 |
| K854551 | MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S | Medipart Jerry Alexander | 1985-12-19 | 36 | 0 |
| K854520 | PULMO-AIDE MODEL 5610D | The Devilbiss Co. | 1985-12-09 | 27 | 0 |
| K852627 | MAXI-NEB | Ashai Co. , Ltd. | 1985-09-26 | 98 | 0 |
| K853071 | MEDIX ELECTRONIC NEBULIZING SYSTEM | Medix Corp. | 1985-08-29 | 37 | 0 |
| K853350 | SYNCHRONER TM (PROPOSED TRADENAME) | Fisons Corp. | 1985-08-29 | 17 | 0 |
| K851525 | PFEIFFER PUMP | Ing. Erich Pfeiffer GmbH & Co. Kg. | 1985-08-08 | 114 | 0 |
| K851254 | MICRO-INHALER MODEL TV-7000 & TV-8000 | Bioclimatic, Inc. | 1985-06-18 | 82 | 0 |
| K850926 | MICRON ONE PORTA. ULTRASONIC NEBULIZER | Endotek Development Laboratories | 1985-05-23 | 79 | 0 |
| K844591 | MIST-EASE NEBULIZER | General Physiotherapy, Inc. | 1984-12-13 | 17 | 0 |
| K843102 | AVA-NEB NEBULIZER | Avatron, Inc. | 1984-08-17 | 10 | 0 |
| K842988 | VMT GENTLE-HALER | Vortran Medical Technology 1, Inc. | 1984-08-07 | 8 | 0 |
| K841989 | ARM-A-VIAL LV SODIUM CHLORIDE INHALAT | Armour Pharmaceutical Co. | 1984-07-27 | 79 | 0 |
| K841991 | ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS | Armour Pharmaceutical Co. | 1984-07-27 | 79 | 0 |
| K841990 | ARM-A-CARE NEBULIZER-NEBULIZER | Armour Pharmaceutical Co. | 1984-07-27 | 79 | 0 |
| K841987 | ARM-A-VIAL LV STERIAL WATER FOR INHALA | Armour Pharmaceutical Co. | 1984-07-27 | 86 | 0 |
| K841988 | ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT | Armour Pharmaceutical Co. | 1984-07-27 | 79 | 0 |
| K842192 | CROUP TENT FRAME | Home Run Treadmill Co. | 1984-06-25 | 21 | 0 |
| K841894 | VMT HAND HELD NEBULIZER | Vortran Medical Technology 1, Inc. | 1984-06-05 | 29 | 0 |
| K841469 | MISTY OX DISPOS. NEBULIZER | Medical Molding Corp. of America | 1984-04-24 | 15 | 0 |
| K841321 | AIR-NEB NEBULIZER COMPRESSOR UNIT | Airmed Corp. | 1984-04-13 | 11 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda