Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BZA — Predicate Candidate Screening
94 FDA 510(k) clearances under this product code; the 50 most recent screened below.
37 daysmedian FDA review time
115 days90th percentile
94clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083702 | TRACH-ASSIST | Mergenet Medical | 2009-03-05 | 80 | 0 |
| K954383 | SURELOC CIRCUIT CONNECTOR | Polamedco, Inc. | 1995-12-22 | 94 | 0 |
| K954197 | DISPOSABLE FLEX TUBE | Engstrom Medical | 1995-10-26 | 50 | 0 |
| K953786 | UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS | Unicor, Inc. | 1995-09-19 | 36 | 0 |
| K952824 | NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR | Intertex Medical, Inc. | 1995-07-20 | 30 | 0 |
| K951345 | DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING | Catheter Research, Inc. | 1995-04-14 | 22 | 0 |
| K944532 | PRIMA, INC. VENTILATOR HOSES | Prima, Inc. | 1994-12-02 | 78 | 0 |
| K944535 | PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS | Prima, Inc. | 1994-11-29 | 75 | 0 |
| K944534 | PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS | Prima, Inc. | 1994-11-29 | 75 | 0 |
| K942392 | AIRWAY CONNECTOR WITH FLEX TUBE | Mallinckrodt Medical | 1994-08-22 | 95 | 0 |
| K941026 | THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR | Thayer Medical Corp. | 1994-08-18 | 167 | 0 |
| K940793 | DOUBLE TRACH SWIVEL CONNECTOR | Seven Harvest Intl. Import & Export | 1994-07-01 | 129 | 0 |
| K940544 | DOUBLE TRACH SEIVEL CONNECTOR | Fvtnks | 1994-04-19 | 71 | 0 |
| K935821 | DOUBLE TRACH SWIVEL CONNECTOR | Nutec, Inc. | 1994-01-14 | 42 | 0 |
| K931800 | MAG CONNECTORS AND AIRWAY EXTENSIONS | Mag, Inc. | 1993-05-19 | 37 | 0 |
| K931345 | CONNECTORS AND AIRWAY EXTENSIONS | Precision Med Products, Ltd. | 1993-04-23 | 37 | 0 |
| K931216 | CONNECTORS AND AIRWAY EXTENSIONS | Teknor Medical Products, Inc. | 1993-04-23 | 44 | 0 |
| K931038 | CONNECTORS AND AIRWAY EXTENSIONS | Med-Plastics Intl., Inc. | 1993-04-08 | 38 | 0 |
| K931036 | CONNECTORS AND AIRWAY EXTENSIONS | Life Shield Healthcare Products, Inc. | 1993-04-08 | 38 | 0 |
| K925263 | MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT | Merit Medical Systems, Inc. | 1993-02-02 | 106 | 0 |
| K922537 | DURALIFE | Dhd Diemolding Healthcare Div. | 1992-12-04 | 190 | 0 |
| K924225 | OXYGEN SWIVEL ADAPTER (PLASTIC) | Linjorel Products, Inc. | 1992-09-04 | 14 | 0 |
| K921512 | ENTENDED LINE ACCESSORIES & CONNECTORS | Intersurgical, Inc. | 1992-06-17 | 85 | 0 |
| K921511 | CATHETER MOUNTS -- MODIFICATION | Intersurgical, Inc. | 1992-06-17 | 85 | 0 |
| K913726 | DURALIFE(TM) | Dhd Diemolding Healthcare Div. | 1992-02-07 | 171 | 0 |
| K913216 | TRACH T ADAPTER | Specialty Packaging Producs, Inc. | 1992-01-15 | 180 | 0 |
| K912652 | FLEX-ELBOW | Vital Signs, Inc. | 1991-10-10 | 115 | 0 |
| K911421 | CATHETER MOUNTS | Intersurgical, Inc. | 1991-06-24 | 139 | 0 |
| K911425 | ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM | Intersurgical, Inc. | 1991-06-24 | 139 | 0 |
| K911294 | ULTRASET CATHETER | Dhd Diemolding Healthcare Div. | 1991-06-10 | 77 | 0 |
| K895549 | M.D.I. ADAPTER | Custom Connection Corp. | 1989-11-21 | 69 | 0 |
| K895014 | BAXTER BAFFLED TEE ADAPTER | Baxter Healthcare Corp | 1989-10-30 | 83 | 0 |
| K894969 | AEROVENT | Monaghan Medical Corp. | 1989-10-30 | 84 | 0 |
| K895388 | SHILEY ELBOW 15MM SWIVEL CONNECTOR | Shiley, Inc. | 1989-10-27 | 58 | 0 |
| K895144 | INTERTECH METERED DOSE ELBOW | Intertech/Ohio | 1989-10-19 | 62 | 0 |
| K884374 | E.T. PUFFER | Kalajian Ent. | 1988-11-23 | 36 | 0 |
| K881849 | BODAI M.D.D. ADAPTOR(TM) | B&B Medical Technologies, Inc. | 1988-07-01 | 60 | 0 |
| K882203 | NEOTECH UNIVERSAL ADAPTER | Neotech Products, Inc. | 1988-06-17 | 23 | 0 |
| K881230 | FLEX TUBE | Intertech Resources, Inc. | 1988-04-14 | 23 | 0 |
| K873696 | BODAI NEO2-SAFE(TM) | B&B Medical Technologies, Inc. | 1988-04-14 | 213 | 0 |
| K880434 | MEDICOMP STRAIGHT SWIVEL ADAPTOR | Medicomp, Inc. | 1988-03-31 | 59 | 0 |
| K873974 | TILSON TRACH GUARD | Beevers Mfg. & Supply, Inc. | 1987-12-22 | 84 | 0 |
| K871737 | CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR | Currie Medical Specialties, Inc. | 1987-06-22 | 48 | 0 |
| K864896 | MEDICOMP INHALANT MASK ELBOW | Medicomp, Inc. | 1987-02-20 | 67 | 0 |
| K865046 | SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE | Salter Labs | 1987-01-15 | 22 | 0 |
| K862435 | DOUBLE LUMEN E T ADAPTOR | Acutronic Medical Systems AG | 1986-10-22 | 118 | 0 |
| K863318 | AEROSOL-T | Southmedic, Inc. | 1986-09-11 | 16 | 0 |
| K862433 | UNI-JET CONNECTOR | Acutronic Medical Systems AG | 1986-08-06 | 41 | 0 |
| K860838 | INSPIRON DOUBLE SWIVEL TRACH ADAPTER | Inspiron Corp. | 1986-04-09 | 35 | 0 |
| K860650 | 90 DEGREE ELBOW & STRAIGHT CONNECTOR | Intertech/Ohio | 1986-03-28 | 35 | 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