Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
BYG — Predicate Candidate Screening
55 FDA 510(k) clearances under this product code; the 50 most recent screened below.
55 daysmedian FDA review time
127 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963298 | FIRST AID KIT(S) | Vector, Inc. | 1996-11-06 | 77 | 0 |
| K962848 | HANS RUDOLPH NASAL CPAP MASK | Hans Rudolph, Inc. | 1996-10-16 | 86 | 0 |
| K945482 | DISPOSABLE, CPAP OXYGEN MASK | Fvtnks | 1995-09-19 | 315 | 0 |
| K953464 | WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK | Westmed, Inc. | 1995-09-18 | 56 | 0 |
| K953039 | VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS | Dadsun Corp., Ltd. | 1995-09-15 | 94 | 0 |
| K945472 | WESTMED PEDIATRIC AND ADULT AEROSOL MASK | Westmed Intl. | 1995-02-07 | 91 | 0 |
| K942907 | JEMSDAL MASK | Respan Products, Inc. | 1994-08-31 | 71 | 0 |
| K940887 | SYSTEM 22 ADULT MASK | Medic-Aid , Ltd. | 1994-04-19 | 53 | 0 |
| K940888 | SYSTEM 22 PAEDIATRIC MASK | Medic-Aid , Ltd. | 1994-04-19 | 53 | 0 |
| K931952 | MEDWAY OXYGEN MASK | Medway | 1993-08-20 | 122 | 0 |
| K924069 | SURGICO OXYGEN MASK | Gujarat Surgico, Ltd. | 1993-02-04 | 177 | 0 |
| K921499 | SEAL RING FOR NASAL CPAP | Devilbiss Health Care, Inc. | 1992-09-17 | 170 | 0 |
| K913501 | TRACHEOSTOMY MASK | B & F Medical Products, Inc. | 1992-01-13 | 159 | 0 |
| K913383 | OXYGEN MASKS 81420, 81421, 81471 & 81461 | Specialty Packaging Producs, Inc. | 1991-10-18 | 81 | 0 |
| K913275 | VENTURI OXYGEN MASK | Specialty Packaging Producs, Inc. | 1991-10-10 | 79 | 0 |
| K913455 | OXYGEN MASKS 82400 & 82405 | Specialty Packaging Producs, Inc. | 1991-10-02 | 61 | 0 |
| K912633 | SALTER LABS INFANT MEDIUM CONCENTRATION MASK | Salter Labs | 1991-07-19 | 35 | 0 |
| K905288 | ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES | Med-Tek Innovations, Inc. | 1991-04-09 | 134 | 0 |
| K904719 | DISPOSABLE FACE MASK | Tri/Bor Medical, Inc. | 1991-01-02 | 76 | 0 |
| K904195 | DISPOSABLE FACE MASK | Bp , Ltd. | 1990-09-25 | 13 | 0 |
| K896773 | DISPOSABLE FACE MASK | Cadema Medical Products, Inc. | 1990-01-12 | 42 | 0 |
| K894642 | SLEEPAP MASK | Medical Industries America, Inc. | 1989-10-19 | 87 | 0 |
| K892434 | KENDALL CURITY OXYGEN MASK | The Kendal Co. | 1989-08-15 | 127 | 0 |
| K890193 | SINGLE PATIENT USE NASAL (CPAP) CIRCUIT | Puritan Bennett Corp. | 1989-03-14 | 55 | 0 |
| K874092 | MASK, OXYGEN | Life Support Products, Inc. | 1988-02-11 | 126 | 0 |
| K870206 | CRYSTAL MASK | Brunswick Mfg. Co., Inc. | 1987-02-20 | 31 | 0 |
| K865047 | SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE | Salter Labs | 1987-02-10 | 48 | 0 |
| K860869 | MEDIUM CONCENTRATION OXYGEN MASKS | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 | 22 | 0 |
| K860871 | TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 | 22 | 0 |
| K860870 | AEROSOL MASKS/ADULT & PAEDIATRIC | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 | 22 | 0 |
| K852624 | OXY-TWO | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K852629 | AERO-MASK TWO | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K852623 | OXY-ONE | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K852626 | AERO-MASK ONE | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K851466 | CARNATION - OXYGEN MASK | Dadsun Corp., Ltd. | 1985-06-19 | 69 | 0 |
| K850626 | CARNATION OXYGEN | Cathay Consolidated, Inc. | 1985-03-12 | 21 | 0 |
| K823532 | STOCK #64091-PEDIATRIC OXYGEN MASK | B & F Medical Products, Inc. | 1983-01-05 | 37 | 0 |
| K823141 | OXYGEN MASKS | Seven Harvest Intl. Import & Export | 1982-11-29 | 35 | 0 |
| K812208 | NASAL OXYGEN CANNULA OXYGEN MASK | Kamei Intl. Corp. | 1981-08-25 | 21 | 0 |
| K811711 | PEDIATRIC OXYGEN MASKS | Airlife, Inc. | 1981-07-01 | 14 | 0 |
| K810340 | ADULT MASKS & PEDIATRIC MASKS | Todd Industries, Inc. | 1981-03-17 | 35 | 0 |
| K802323 | PEDIATRIC OXYGEN OR AEROSOL MASKS, | Airlife, Inc. | 1980-10-03 | 10 | 0 |
| K801883 | PEEP FACE MASK | Vital Signs, Inc. | 1980-09-09 | 33 | 0 |
| K790934 | OXYGEN BARB M-552 | Mem Medical, Inc. | 1979-05-21 | 6 | 0 |
| K790166 | OXYGEN MASK, ADULT VINYL | Airlife, Inc. | 1979-03-16 | 63 | 0 |
| K790163 | AEROSOL MASK | Airlife, Inc. | 1979-02-16 | 35 | 0 |
| K790164 | OXYGEN MASK REBREATHER | Airlife, Inc. | 1979-02-06 | 25 | 0 |
| K790165 | OXYGEN MASK-HIGH CONCENTRATION | Airlife, Inc. | 1979-02-06 | 25 | 0 |
| K781741 | MASK, BI FLO NASAL OXYGEN | Inhal-O-Tech Medical Plastic | 1978-12-01 | 55 | 0 |
| K781055 | FACE TENTS | Hospitak, Inc. | 1978-07-17 | 24 | 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