Atlas FDA

BZA

94 FDA 510(k) clearances · Product code

37 daysmedian time to decision
115 days90th percentile
94clearances measured

FDA profile

Official device name
Connector, Airway (Extension)
Device class
Class I (low risk)
Regulation
21 CFR 868.5810
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2020: 21 · 2021: 15 · 2022: 21 · 2023: 38 · 2024: 28 · 2025: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
TRACH-ASSIST (K083702)Mergenet Medical2009-03-05
SURELOC CIRCUIT CONNECTOR (K954383)Polamedco, Inc.1995-12-22
DISPOSABLE FLEX TUBE (K954197)Engstrom Medical1995-10-26
UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (K953786)Unicor, Inc.1995-09-19
NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (K952824)Intertex Medical, Inc.1995-07-20
DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (K951345)Catheter Research, Inc.1995-04-14
PRIMA, INC. VENTILATOR HOSES (K944532)Prima, Inc.1994-12-02
PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (K944535)Prima, Inc.1994-11-29
PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (K944534)Prima, Inc.1994-11-29
AIRWAY CONNECTOR WITH FLEX TUBE (K942392)Mallinckrodt Medical1994-08-22
THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR (K941026)Thayer Medical Corp.1994-08-18
DOUBLE TRACH SWIVEL CONNECTOR (K940793)Seven Harvest Intl. Import & Export1994-07-01
DOUBLE TRACH SEIVEL CONNECTOR (K940544)Fvtnks1994-04-19
DOUBLE TRACH SWIVEL CONNECTOR (K935821)Nutec, Inc.1994-01-14
MAG CONNECTORS AND AIRWAY EXTENSIONS (K931800)Mag, Inc.1993-05-19
CONNECTORS AND AIRWAY EXTENSIONS (K931345)Precision Med Products, Ltd.1993-04-23
CONNECTORS AND AIRWAY EXTENSIONS (K931216)Teknor Medical Products, Inc.1993-04-23
CONNECTORS AND AIRWAY EXTENSIONS (K931038)Med-Plastics Intl., Inc.1993-04-08
CONNECTORS AND AIRWAY EXTENSIONS (K931036)Life Shield Healthcare Products, Inc.1993-04-08
MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT (K925263)Merit Medical Systems, Inc.1993-02-02
DURALIFE (K922537)Dhd Diemolding Healthcare Div.1992-12-04
OXYGEN SWIVEL ADAPTER (PLASTIC) (K924225)Linjorel Products, Inc.1992-09-04
ENTENDED LINE ACCESSORIES & CONNECTORS (K921512)Intersurgical, Inc.1992-06-17
CATHETER MOUNTS -- MODIFICATION (K921511)Intersurgical, Inc.1992-06-17
DURALIFE(TM) (K913726)Dhd Diemolding Healthcare Div.1992-02-07
TRACH T ADAPTER (K913216)Specialty Packaging Producs, Inc.1992-01-15
FLEX-ELBOW (K912652)Vital Signs, Inc.1991-10-10
CATHETER MOUNTS (K911421)Intersurgical, Inc.1991-06-24
ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM (K911425)Intersurgical, Inc.1991-06-24
ULTRASET CATHETER (K911294)Dhd Diemolding Healthcare Div.1991-06-10
M.D.I. ADAPTER (K895549)Custom Connection Corp.1989-11-21
BAXTER BAFFLED TEE ADAPTER (K895014)Baxter Healthcare Corp1989-10-30
AEROVENT (K894969)Monaghan Medical Corp.1989-10-30
SHILEY ELBOW 15MM SWIVEL CONNECTOR (K895388)Shiley, Inc.1989-10-27
INTERTECH METERED DOSE ELBOW (K895144)Intertech/Ohio1989-10-19
E.T. PUFFER (K884374)Kalajian Ent.1988-11-23
BODAI M.D.D. ADAPTOR(TM) (K881849)B&B Medical Technologies, Inc.1988-07-01
NEOTECH UNIVERSAL ADAPTER (K882203)Neotech Products, Inc.1988-06-17
FLEX TUBE (K881230)Intertech Resources, Inc.1988-04-14
BODAI NEO2-SAFE(TM) (K873696)B&B Medical Technologies, Inc.1988-04-14
MEDICOMP STRAIGHT SWIVEL ADAPTOR (K880434)Medicomp, Inc.1988-03-31
TILSON TRACH GUARD (K873974)Beevers Mfg. & Supply, Inc.1987-12-22
CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR (K871737)Currie Medical Specialties, Inc.1987-06-22
MEDICOMP INHALANT MASK ELBOW (K864896)Medicomp, Inc.1987-02-20
SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE (K865046)Salter Labs1987-01-15
DOUBLE LUMEN E T ADAPTOR (K862435)Acutronic Medical Systems AG1986-10-22
AEROSOL-T (K863318)Southmedic, Inc.1986-09-11
UNI-JET CONNECTOR (K862433)Acutronic Medical Systems AG1986-08-06
INSPIRON DOUBLE SWIVEL TRACH ADAPTER (K860838)Inspiron Corp.1986-04-09
90 DEGREE ELBOW & STRAIGHT CONNECTOR (K860650)Intertech/Ohio1986-03-28
STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG (K861056)Intertech/Ohio1986-03-27
STRAIGHT CONNECTORS, 15MM, 30MM & 19MM (K860885)Dhd Medical Products Div. Diemolding Corp.1986-03-20
DISPOSABLE CATHETER (K860882)Dhd Medical Products Div. Diemolding Corp.1986-03-20
BRITISH BREATHING CIRCUIT SYSTEM (K860878)Dhd Medical Products Div. Diemolding Corp.1986-03-20
STRAIGHT CONNECTORS, 22MM (K860886)Dhd Medical Products Div. Diemolding Corp.1986-03-19
CONNECTORS/VALVE INSERT (K860888)Dhd Medical Products Div. Diemolding Corp.1986-03-19
CATHETER MOUNTS & ELBOWS (VARIOUS TYPES) (K860881)Dhd Medical Products Div. Diemolding Corp.1986-03-19
T-PIECES CONNECTORS (K860887)Dhd Medical Products Div. Diemolding Corp.1986-03-19
SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014 (K860352)Spacelabs, Inc.1986-03-19
FLS MED. PROD. RACINE TYPE ADAPTOR (K853828)Fls Medical Products, Inc.1985-10-29
DOUBLE-SWIVEL CONNECTOR (K850964)Sheridan Catheter Corp.1985-05-14
ARGYLE 15MM SWIVEL CONNECTOR (K850625)Sherwood Medical Co.1985-03-21
OHMEDA DOUBLE SWIVEL ADAPTER (K844656)Ohmeda Medical1985-02-12
SWIVEL ADAPTOR W/ALARM PORT (K840015)Portex, Inc.1984-01-17
BODIA TRACH-SAF DOUBLE SWIVEL (K833372)Sontek Industries, Inc.1983-11-03
BODIA BRONCH-SAF DOUBLE SWIVEL (K833373)Sontek Industries, Inc.1983-11-03
DISPOSABLE TRACH SWIVEL CONNECTOR (K813383)Intec.1981-12-31
RESPIRATORY CARE MONITOR (K812977)Advanced Medical Equipment, Inc.1981-11-16
INSPIRATORY FORCE PRESSURE ADAPTOR (K812067)Airlife, Inc.1981-08-12
PEDIATRIC DOUBLE SWIVEL CONNECTOR (K812000)Mallinckrodt Critical Care1981-08-03
45DEGREES SWIVEL ELBOW (K811922)Dhd Medical Products Div. Diemolding Corp.1981-07-23
DISPOSABLE TRACH T OXYGENATOR (K811890)Airlife, Inc.1981-07-15
UNIVERSAL ADAPTER SYSTEM-U/ADAPIT (K811708)Airlife, Inc.1981-07-01
DISPOSABLE 22MM. FLEXIBLE ADAPTOR (K810621)Intec Medical, Inc.1981-04-17
DISPOSABLE ELBOW ADAPTOR (K810620)Intec Medical, Inc.1981-03-20
CONNECTOR ADAPTERS (K810361)Todd Industries, Inc.1981-03-17
BLOW-BY-SET-UP CONNECTOR-AIRWAY (K802663)Airlife, Inc.1980-11-12
DISPOSABLE 22MM ADAPTOR (K791539)Hospitak, Inc.1979-09-07
DISPOSABLE AEROSOL T (K791538)Hospitak, Inc.1979-09-07
SURELOC EXTERNAL CONNECTOR (K791532)Polamedco, Inc.1979-09-04
TRACH T WITH ONE-WAY VALVES (K790888)Airlife, Inc.1979-06-27
TEE ADAPTER (K790887)Airlife, Inc.1979-06-05
TRACH T W/DRAINAGE BAG (K790156)Airlife, Inc.1979-04-20
VENTILATOR ELBOW W/SUCTION PORT (K790155)Airlife, Inc.1979-02-01
TRACH T ADAPTER (K790157)Airlife, Inc.1979-02-01
MASK INTULATION ADAPTOR (K790149)Airlife, Inc.1979-02-01
CUFF CONNECTOR (K790148)Airlife, Inc.1979-02-01
RESCAL (K781759)Diemolding Corp.1978-11-27
DISPOSABLE AEROSOL T BRIGGS ADAPTOR (K781395)Inhal-O-Tech Medical Plastic1978-08-31
ADAPTER, UNIVERSAL, BE 105-6 (K770630)Instrumentation Industries, Inc.1977-05-23
ADAPTER BE 105-101 & 125-101 (K770634)Instrumentation Industries, Inc.1977-04-08
AEROSOL T ADAPTER, #752 (K770585)Surgicot, Inc.1977-04-05
VENTILATOR ADAPTOR, #751 (K770587)Surgicot, Inc.1977-04-05
VITAL-LOK TRACHEAL SWIVEL COUPLING (K770052)V.F.P. Corp.1977-01-14

Track BZA automatically

Every clearance here is in the API, with alerts when new ones post.