Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
CAE — Predicate Candidate Screening
57 FDA 510(k) clearances under this product code; the 50 most recent screened below.
49 daysmedian FDA review time
232 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130304 | LMA FAMILY OF AIRWAYS | The Laryngeal Mask Co., Ltd. | 2014-05-30 | 477 | 0 |
| K033189 | KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CH | King Systems Corp. | 2004-05-04 | 216 | 0 |
| K033186 | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, K | King Systems Corp. | 2004-04-14 | 196 | 30 |
| K021634 | KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 10 | King Systems Corp. | 2003-01-09 | 237 | 30 |
| K955721 | CUFFED OROPHARYNGEAL AIRWAY (COPA) | Mallinckrodt Medical | 1997-03-28 | 466 | 0 |
| K960240 | RUSCH OPTOSAFE | Rusch Intl. | 1996-04-19 | 94 | 0 |
| K950613 | KEISEI | Keisei (Usa) Co., Ltd. | 1996-02-14 | 369 | 0 |
| K953400 | GUEDEL AIRWAY | Mallinckrodt Medical | 1995-10-24 | 96 | 0 |
| K933760 | STB GUEDEL AIRWAY | Save-T-Breath Distributors C.C. | 1994-03-23 | 232 | 0 |
| K936134 | BERMAN AIRWAY | Smiths Industries Medical Systems, Inc. | 1994-01-28 | 36 | 0 |
| K922748 | GUEDEL AIRWAY | Oem Medical Div. | 1992-07-10 | 32 | 0 |
| K913680 | BERMAN INTUBATING/PHARYNGEAL AIRWAY | Chain Plastics Operations, Inc. | 1991-10-10 | 52 | 0 |
| K904834 | INTAVENT LARYNGEAL MASK | Intavent Intl. S.A. | 1991-07-26 | 275 | 0 |
| K891926 | KISS OF LIFE | Anthony Don Michael, M.D. | 1989-08-21 | 146 | 0 |
| K892123 | GOETTINGER EMERGENCY RESUSCITATION TUBE | Plastic Parts Corp. | 1989-07-14 | 102 | 0 |
| K891586 | ORAL AIRWAY | Dynarex Corp. | 1989-05-11 | 52 | 0 |
| K892053 | RESPAKIT | Protectical Health & Safety , Ltd. | 1989-04-27 | 29 | 0 |
| K890566 | BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES | Medi-Source, Inc. | 1989-03-15 | 37 | 0 |
| K883593 | #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY | Ecolab, Inc. | 1988-09-30 | 38 | 0 |
| K881065 | RESUS-AID | Applied Convergent Technologies, Inc. | 1988-07-14 | 122 | 0 |
| K880241 | 'HILT-WAY' RESUSCITATOR | Medifield , Ltd. | 1988-03-31 | 71 | 0 |
| K874412 | THE PROTECTOR | Tri Jon, Inc. | 1988-02-12 | 107 | 0 |
| K871403 | MODIFIED C.P.R. MICROSHIELD | Westmark Enterprises, Inc. | 1987-05-04 | 26 | 0 |
| K861482 | RESUSIKIT | Begley Enterprises, Inc. | 1986-06-17 | 56 | 0 |
| K862199 | MEDTECH C.P.R. MASK | The Medtech Group, Inc. | 1986-06-13 | 3 | 0 |
| K860949 | DUAL-AID | Vitalograph , Ltd. | 1986-05-06 | 55 | 0 |
| K861540 | DISPOSABLE BERMAN AND GUEDEL AIRWAYS | Dryden Corp. | 1986-05-02 | 8 | 0 |
| K861054 | DISPOSABLE RESCUE BREATHING DEVICE | B & F Medical Products, Inc. | 1986-04-09 | 21 | 0 |
| K860780 | PLASTIC MOUTH BARRIER HCV-E | Westmark Enterprises, Inc. | 1986-04-02 | 30 | 0 |
| K855137 | CURITY FIBEROPTIC INTUBATING AIRWAY | The Kendal Co. | 1986-03-11 | 78 | 0 |
| K854029 | RESPIRATORY RESUSCITATION DEVICE | John H. Harrison | 1986-03-11 | 161 | 0 |
| K850248 | DISPOSABLE GUEDEL AIRWAY | Inmed Corp. | 1985-03-12 | 49 | 0 |
| K844873 | PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4 | Pennine Medical , Ltd. | 1985-02-21 | 66 | 0 |
| K842605 | RESPIRONICS VENT EASY OXYGEN ENRICHME | Respironics, Inc. | 1984-07-27 | 22 | 0 |
| K841429 | MOUTH TO MASK EMERGENCY VENTILATION | O-Two Systems Intl., Inc. | 1984-04-17 | 11 | 0 |
| K841120 | RES-Q-MATE | Rsq Industries, Inc. | 1984-04-05 | 21 | 0 |
| K832512 | AIRWAY MASKS | Artec Environmental Monitoring Division | 1984-01-17 | 174 | 0 |
| K833328 | RESPIRONICS RESCUE DOME | Respironics, Inc. | 1983-12-16 | 80 | 0 |
| K833482 | WISDOM AIRWAY | Wisdom Corp. | 1983-12-05 | 59 | 0 |
| K832435 | BROOK LIFE SAVING AIRWAY DEVICE #900 & | La Societe Fianciere Senefin | 1983-10-04 | 71 | 0 |
| K832471 | ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III | Inmed Corp. | 1983-09-12 | 48 | 0 |
| K831078 | STRAITH ORAL AIRWAY | Surgical Technology Laboratories, Inc. | 1983-06-24 | 81 | 0 |
| K830767 | WILLIAMS AIRWAY INTUBATOR | Williams Airway Intubator | 1983-03-31 | 20 | 0 |
| K822727 | RESCUER | Armstrong Ind., Inc. | 1982-09-28 | 20 | 0 |
| K820709 | AIRWAYS | Seven Harvest Intl. Import & Export | 1982-06-25 | 99 | 0 |
| K821308 | ESPREE' GUEDEL ESPREE BERMAN AIRWAY | Esp Plastics, Inc. | 1982-05-21 | 17 | 0 |
| K820512 | 7CM BERMAN AIRWAY | Vital Signs, Inc. | 1982-03-26 | 29 | 0 |
| K812822 | RIND AIRWAY | Rind Medical Development | 1981-11-16 | 39 | 0 |
| K810651 | ORAL AIRWAYS | First Industries, Inc. | 1981-03-31 | 21 | 0 |
| K810123 | THE LUOMANEN ORAL AIRWAY | Luomanen Medical Products | 1981-02-26 | 38 | 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