Atlas FDA

CAI

184 FDA 510(k) clearances · Product code

50 daysmedian time to decision
176 days90th percentile
184clearances measured

FDA profile

Official device name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device class
Class I (low risk)
Regulation
21 CFR 868.5240
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2021: 138 · 2022: 244 · 2023: 251 · 2024: 117 · 2025: 108 · 2026: 67
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CONDENSATE COLLECTION KIT (K954480)Nova-Ventrx1995-12-29
UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (K953788)Unicor, Inc.1995-09-19
UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (K953787)Unicor, Inc.1995-09-19
PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (K952014)Prima, Inc.1995-05-22
PRIMA ADULT GAS SAMPLING CIRCUITS (K952019)Prima, Inc.1995-05-22
PRIMA COAXIAL CIRCUITS (K952018)Prima, Inc.1995-05-22
PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (K952016)Prima, Inc.1995-05-22
PRIMA MAPLESON D CIRCUIT (K952017)Prima, Inc.1995-05-22
PRIMA PEDIATRIC ANESTHESIA CIRCUITS (K952020)Prima, Inc.1995-05-22
PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (K952009)Prima, Inc.1995-05-19
SPIRO-FLEX (K945565)Inhalation Plastics1995-01-13
NEONATAL BREATHING CIRCUIT MODIFICATION (K932288)Simplex Medical Systems, Inc.1994-12-30
MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS (K945984)Meridian Medical Systems, Inc.1994-12-27
PRIMA, INC. ADULT ANESTHESIA CIRCUIT (K944533)Prima, Inc.1994-11-29
PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING (K944429)Precision Thermoplastic Components, Inc.1994-11-18
CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING (K945314)Cleveland Tubing, Inc.1994-11-18
CORRUGATED TUBING (K940890)Cleveland Tubing, Inc.1994-11-10
CONNECTORS AND AIRWAY EXTENSIONS (K940889)Cleveland Tubing, Inc.1994-11-10
KARL STORZ LARYNGOSCOPE ACCESSORIES (K944295)KARL STORZ Endoscopy-America, Inc.1994-10-04
M.A.G. INC. ADULT GAS SAMPLING CIRCUITS (K942128)Mag, Inc.1994-06-22
M.A.G. INC. VENTILATOR HOSES (K942123)Mag, Inc.1994-06-22
M.A.G. INC. COAXIAL CIRCUITS (K942135)Mag, Inc.1994-06-22
M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS (K942136)Mag, Inc.1994-06-22
M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUIT (K942126)Mag, Inc.1994-06-22
M.A.G. INC. HYPERINFLATION SYSTEM (K942132)Mag, Inc.1994-06-22
M.A.G INC. ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (K942129)Mag, Inc.1994-06-22
PEDIATRIC ANESTHESIA CIRCUITS (K942122)Mag, Inc.1994-06-22
M.A.G. INC. CUSTOM ANESTHESIA CIRCUITS (K942133)Mag, Inc.1994-06-22
M.A.G. INC. GUEDEL AIRWAYS (K942131)Mag, Inc.1994-06-22
M.A.G INC. PEDIATRIC GAS SAMPLING CIRCUITS (K942127)Mag, Inc.1994-06-22
M.A.G. INC. MAPLESON D CIRCUITS (K942130)Mag, Inc.1994-06-22
VOLUME VENTILATOR (K942125)Mag, Inc.1994-06-22
GAS SAMPLING LINES AND CONNECTORS CIRCUITS (K942124)Mag, Inc.1994-06-22
M.A.G. INC. BREALTHING BAGS (K942134)Mag, Inc.1994-06-22
ADULT ANESTHESIA BREATHING CIRCUIT (K942568)Med-Plastics Intl., Inc.1994-06-10
MAPLESON D CIRCUIT (K942570)Med-Plastics Intl., Inc.1994-06-10
ADULT ANESTHESIA BREATHING CIRCUIT KITS (K934462)Zefon Medical Products1994-03-01
ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITS (K935168)Bill Olson Corp.1994-02-07
MALE/MALE LUER TRANSFER TUBING (K932780)Innovations For Mechanical Ventilation, Inc.1994-01-24
DUAL VALVED RESPIRATORY T (K932781)Innovations For Mechanical Ventilation, Inc.1994-01-24
BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE (K931487)Bird Life Design1993-12-16
EASYFLOW AIRWAY ADAPTER (K935044)Easyflow Airway Systems, Inc.1993-11-18
BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLE (K933641)Bird Life Design1993-10-15
THE INFANT FLOW SYSTEM (K930713)Sechrist Industries, Inc.1993-09-16
GAS SAMPLING LINES AND CONNECTORS (K932562)Life Shield Healthcare Products, Inc.1993-07-23
PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS (K932708)Precision Med Products, Ltd.1993-07-23
GAS SAMPLING LINES AND CONNECTORS (K932710)Precision Med Products, Ltd.1993-07-23
ADULT ANESTHESIA BREATHING CIRCUIT (K932707)Precision Med Products, Ltd.1993-07-23
PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING (K932497)Precision Med Products, Ltd.1993-07-22
ADULT GAS SAMPLING CIRCUITS (K932590)Merit Medical Systems, Inc.1993-07-22
PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR. (K932489)Precision Med Products, Ltd.1993-07-22
ADULT ANESTHESIA BREATHING CIRCUIT (K932558)Life Shield Healthcare Products, Inc.1993-07-22
PMP, LTD. PEDIATRIC GAS SAMPLING CIRCUITS (K932488)Precision Med Products, Ltd.1993-07-22
PEDIATRIC TEMPERATURE MONITORING CIRCUITS (K932576)Med-Plastics Intl., Inc.1993-07-22
ADULT GAS SAMPLING CIRCUITS (K932578)Med-Plastics Intl., Inc.1993-07-22
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (K932575)Med-Plastics Intl., Inc.1993-07-22
PEDIATRIC GAS SAMPLING (K932577)Med-Plastics Intl., Inc.1993-07-22
PEDIATRIC GAS SAMPLING CIRCUITS (K932589)Merit Medical Systems, Inc.1993-07-22
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (K932583)Merit Medical Systems, Inc.1993-07-21
PMP, LTD. PEDIATRIC TEMPERATURE MONITORING CIRCUIT (K932486)Precision Med Products, Ltd.1993-07-21
PEDIATRIC TEMPERATURE MONITORING CIRCUITS (K932588)Merit Medical Systems, Inc.1993-07-21
COAXIAL CIRCUITS (K932587)Merit Medical Systems, Inc.1993-07-16
COAXIAL CIRCUITS (K932579)Med-Plastics Intl., Inc.1993-07-16
CUSTOM ANESTHESIA CIRCUITS (K932582)Med-Plastics Intl., Inc.1993-07-16
CUSTOM ANESTHESIA CIRCUITS (K932586)Merit Medical Systems, Inc.1993-07-16
MAPLESON D CIRCUITS (K932559)Life Shield Healthcare Products, Inc.1993-07-16
PEDIATRIC ANESTHESIA CIRCUITS (K932580)Med-Plastics Intl., Inc.1993-07-16
PEDIATRIC ANESTHESIA CIRCUITS (K932585)Merit Medical Systems, Inc.1993-07-16
PMP, LTD. CUSTOM ANESTHESIA CIRCUITS (K932490)Precision Med Products, Ltd.1993-07-14
PMP, LTD. PEDIATRIC ANESTHESIA CIRCUITS (K932487)Precision Med Products, Ltd.1993-07-13
PRECISION MED PRODUCTS, LTD. COAXIAL CIRCUITS (K932485)Precision Med Products, Ltd.1993-07-13
ADULT GAS SAMPLING CIRCUITS (K932195)Life Shield Healthcare Products, Inc.1993-07-02
COAXIAL CIRCUITS (K932196)Life Shield Healthcare Products, Inc.1993-07-02
PEDIATRIC ANESTHESIA CIRCUITS (K932192)Life Shield Healthcare Products, Inc.1993-07-02
PEDIATRIC GASSAMPLING CIRCUITS (K932194)Life Shield Healthcare Products, Inc.1993-07-02
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (K932190)Life Shield Healthcare Products, Inc.1993-07-02
CUSTOM ANESTHESIA CIRCUITS (K932197)Life Shield Healthcare Products, Inc.1993-07-02
PEDIATRIC TEMPERATURE MONITORING CIRCUITS (K932193)Life Shield Healthcare Products, Inc.1993-07-02
ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON (K926454)Medical, Inc.1993-06-22
KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT (K922789)King Systems Corp.1993-05-26
BLD-18000 SERIES HEATED BREATHING CIRCUIT (K925543)Bird Life Design1993-04-30
XTEND CIRCUITS (TM) (K924627)Arc Medical, Inc.1993-04-07
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT (K924889)Zefon Medical Products1993-03-19
OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT (K925893)Oem Medical Div.1993-03-12
BABYSET AND PAC (PULMONARY ASSIST CIRCUIT) (K930252)Bird Life Design1993-02-09
MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITS (K925231)Merit Medical Systems, Inc.1993-01-26
MERIDIAN MEDICAL SYSTEMS ADULT ANES BREATH CIRCUIT (K925232)Merit Medical Systems, Inc.1993-01-22
ANESTHESIA BREATHING CIRCUIT (K915452)Concord/Portex1992-02-14
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT (K911880)Bill Olson Corp.1991-12-20
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED (K912504)Intertech Resources, Inc.1991-10-23
BODAI NEO2 -SAFE AIRWAY PRESSURE CAP (K913753)B&B Medical Technologies, Inc.1991-10-23
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED (K912065)Intertech Resources, Inc.1991-10-23
22MM ID/OD ADAPTER (K911263)Monaghan Medical Corp.1991-08-19
MEDICAL ASSEMBLIES ADULT ANESTHESIA BREATH CIRCUIT (K911736)Medical Assemblies, Inc.1991-07-11
ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE (K905450)Vital Signs, Inc.1991-07-01
DISPOSABLE ANESTHESIA BREATHING CIRCUIT (K910896)Specialty Packaging Producs, Inc.1991-05-08
MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT (K904538)Mauna Loa Medical, Inc.1991-04-24
TEMPERATURE PROBE (K905148)Tec II Medical, Inc.1991-04-01
THAYER METERED DOSE INHALER DISPENSER/ADAPTER (K901739)Thayer Medical Corp.1990-10-09
ANESTHESIA BREATHING CIRCUITS (K900428)Med-Tek Corp.1990-08-17
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