Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BSJ — Predicate Candidate Screening
51 FDA 510(k) clearances under this product code; the 50 most recent screened below.
29 daysmedian FDA review time
108 days90th percentile
51clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163277 | SuperNO2VA Device | Revolutionary Medical Devices, Inc. | 2017-10-13 | 326 | 0 |
| K953107 | ANESTHESIA/RESPIRATORY FACE MASK | Medical Marketing Concepts | 1995-08-15 | 43 | 0 |
| K953295 | ANESTHESIA FACE MASK | Mallinckrodt Medical | 1995-08-11 | 28 | 0 |
| K952689 | BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK | Owens-Brigam Medical Co. | 1995-07-11 | 29 | 0 |
| K951043 | AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK | Promedic, Inc. | 1995-06-07 | 92 | 0 |
| K950771 | DISPOSABLE ADHESIVE FACE MASK | Advanced Warming Systems, Inc. | 1995-03-10 | 382 | 0 |
| K945894 | MASK, GAS, ANESTHETIC | Hans Rudolph, Inc. | 1995-01-27 | 56 | 0 |
| K945440 | DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK | Fvtnks | 1994-11-08 | 1 | 0 |
| K944157 | DISPOSABLE, PREFORMED FACE MASK | Meridian Medical Systems, Inc. | 1994-10-03 | 38 | 0 |
| K932147 | NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE | Hans Rudolph, Inc. | 1993-08-20 | 108 | 0 |
| K932014 | AMBU DISPOSABLE FACE MASK | Ambu, Inc. | 1993-06-22 | 60 | 0 |
| K915558 | IAS ANESTHESIA MASK | Ias | 1992-04-08 | 119 | 0 |
| K903881 | VENTLAB VENT-MASK, CAT# VR 0010/20/30 | Ventlab Corp. | 1990-09-04 | 13 | 0 |
| K902298 | ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS | Rondex Products, Inc. | 1990-08-22 | 92 | 0 |
| K891316 | ANESTHESIA/RESPIRATORY DISPOSABLE MASK | Concord/Portex | 1989-08-21 | 161 | 0 |
| K884157 | MODIFIED TOUCH-ME-NOT MASK | Walt'S Products | 1989-08-21 | 321 | 0 |
| K890795 | RESPIRONICS SEALEASY II | Respironics, Inc. | 1989-04-20 | 62 | 0 |
| K890108 | MODIFIED CUSHION-FLEX(TM) | Life Design Systems, Inc. | 1989-01-24 | 21 | 0 |
| K884387 | CUSHION FLEX(TM) | Life Design Systems, Inc. | 1988-11-17 | 30 | 0 |
| K882434 | MASK, GAS, ANESTHETIC | Eastmed Enterprises, Inc. | 1988-06-30 | 16 | 0 |
| K881393 | RONDEX RESCUE MASK | Rondex Products, Inc. | 1988-04-25 | 21 | 0 |
| K881067 | NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK | Medesign, Inc. | 1988-03-24 | 10 | 0 |
| K880682 | MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP | King Systems Corp. | 1988-03-21 | 31 | 0 |
| K874746 | SEALFLEX MASK | Engineered Medical Systems | 1987-12-21 | 33 | 1 |
| K872015 | SPIRASEAL(TM) FACE MASK (VARIOUS SIZES) | Brigam, Inc. | 1987-06-17 | 22 | 0 |
| K871851 | RIBBED CUSHION MASK | Engineered Medical Systems | 1987-06-08 | 27 | 0 |
| K862784 | MP-XMO DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862783 | MP-XMV DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862781 | MP-XMM DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862782 | MP-XML DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K860686 | FACEGLOV,ANESTHETIC GAS MASK | Loran , Ltd. | 1986-04-30 | 64 | 0 |
| K853785 | SERIES 2000 MEDS MASK | Med Systems | 1985-12-03 | 84 | 0 |
| K854161 | SUR-FIT FACE MASK | Anesthesia Respiratory Technology, Inc. | 1985-11-05 | 25 | 0 |
| K850263 | PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY | Plasmedics, Inc. | 1985-03-25 | 61 | 0 |
| K844493 | MEDIPART FACE MASK & FILTER MP-30XM | Medipart Jerry Alexander | 1984-12-04 | 14 | 0 |
| K844494 | MEDIPART FACE MASK MP-XM | Medipart Jerry Alexander | 1984-12-04 | 14 | 0 |
| K843169 | CUSHION-FLEX TM | Life Design Systems, Inc. | 1984-08-20 | 7 | 0 |
| K842472 | DRYDEN INFLATABLE MASK | Dryden Corp. | 1984-07-06 | 11 | 0 |
| K841240 | DISPOSABLE ANESTHESIA MASK | Hospitak, Inc. | 1984-04-05 | 13 | 0 |
| K840535 | DISPOS. ANESTHESIA FACE MASK | Marquest Medical Products, Inc. | 1984-02-21 | 13 | 0 |
| K840452 | PREMIUM DABM DISPOS. ANES. BREATH MASK | Ohio Medical Products | 1984-02-17 | 16 | 0 |
| K834536 | CRYSTALCONE FACE MASK-MED-W/HOOKRING | Warne Surgical Products, Ltd. | 1984-01-25 | 34 | 0 |
| K834454 | PAEDIATRIC FACE MASK 1-3 W/WO RING | Warne Surgical Products, Ltd. | 1984-01-18 | 30 | 0 |
| K831713 | NON CONDUCTIVE ANESTHESIA FACEMASK | Vital Signs, Inc. | 1983-07-07 | 41 | 0 |
| K830982 | MASKS | Medovations, Inc. | 1983-05-09 | 41 | 0 |
| K821045 | NON CONDUCTIVE PEDIATRIC ANES. FACE | Vital Signs, Inc. | 1982-04-26 | 12 | 0 |
| K810990 | OHIO NONCONDUCTIVE RBS TYPE FACE MASK | Ohio Medical Products | 1981-04-23 | 10 | 0 |
| K803185 | NON-CONDUCTIVE ANESTHESIA FACE MASK | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-01-05 | 20 | 0 |
| K801251 | NON-CONDUCTIVE, SINGLE USE FACE MASK #55 | Vital Signs, Inc. | 1980-06-04 | 7 | 0 |
| K790638 | ACCUTRON POLLUTION REDUCER | Parker Laboratories, Inc. | 1979-05-25 | 56 | 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