Atlas FDA

BSY

116 FDA 510(k) clearances · Product code

62 daysmedian time to decision
160 days90th percentile
116clearances measured

FDA profile

Official device name
Catheters, Suction, Tracheobronchial
Device class
Class I (low risk)
Regulation
21 CFR 868.6810
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2021: 63 · 2022: 309 · 2023: 198 · 2024: 210 · 2025: 164 · 2026: 56
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM (K031997)Mallinckrodt Dar S.R.L.2003-11-25
AMBU HAND POWER SUCTION PUMP (K992902)Ambu, Inc.1999-10-25
DUAL PURPOSE CLOSED CATHETER (K982945)Spirit Medical Systems, Inc.1998-09-22
SUCTION CATHETER (K981910)Ni-Med, Inc.1998-08-24
HI-CARE CLOSED SUCTION SYSTEM (K972258)Mallinckrodt Medical1997-12-29
AMSINO SUCTION CATHETER (K973199)Amsino Intl., Inc.1997-09-10
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (K961707)Sorenson Critical Care1997-03-11
TRACH CARE SET WITH MICROBAN (K964369)Ballard Medical Products1997-02-11
NEO 2 LINE SUCTION SYSTEM (K960488)Alcove Medical, Inc.1996-04-26
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (K955831)Sherwood Medical Co.1996-03-28
CATH-GUIDE (K955645)Hudson Respiratory Care, Inc.1996-03-12
REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION (K952396)Contour Fabricators of Florida, Inc.1995-08-15
REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION (K952395)Contour Fabricators of Florida, Inc.1995-08-15
PULM O2 SUCTION CATHETER TRAYS (K953226)Premium Plastics, Inc.1995-08-08
SUCTION CATHETER KIT, STERILE, SINGLE-USE (K951506)Trinity Laboratories, Inc.1995-07-03
DUAL PURPOSE CATHETER (K945994)Universal Medical Products, Inc.1995-06-21
CONNECTING TUBE (K951745)Vital Signs, Inc.1995-05-30
TRIGUARD(TM) SUCTION SYSTEM (K945950)Vital Signs, Inc.1994-12-27
KENDALL MODU-VAC CLOSED SUCTION SYSTEM (K944251)Kendall Healthcare Products Co. Div.Of Tyco Health1994-09-21
TRACHEAL SUCTION CATHETER (K935600)Puritas Health Care, Inc.1994-05-10
SUCTION SET, TRACHAEL (K935583)Puritas Health Care, Inc.1994-04-11
MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP (K935553)Puritas Health Care, Inc.1994-01-14
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (K934723)Sherwood Medical Co.1993-11-30
ARGYLE ASPIR-FLEX SUCTION CATHETER (K925556)Sherwood Medical Co.1993-07-30
4 SURE TM SUCTION CATHETERS & KITS (K921851)Boston Pacific Medical, Inc.1993-07-07
DYNAREX SUCTION CATHETERS & KITS (K922843)Dynarex Corp.1993-01-11
ARGYLE AERO-JET SUCTION CATHETER (K922148)Sherwood Medical Co.1992-12-07
STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE (K923098)Trinity Laboratories, Inc.1992-09-21
HANN-VAC TM, DISPOSABLE,SUCTION CATHETER (K903480)Un-I-Med, Inc.1991-10-01
MECONIUM ASPIRATION (K912596)Pacific Device, Inc.1991-07-30
NEBU-SOL METERED DOSE DISPENSER (TM) (K910239)Dey Laboratories, Inc.1991-05-22
MUCAID (K910909)Vygon Corp.1991-05-20
MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING (K910908)Vygon Corp.1991-05-20
ORAL-CATH SUCTION CATHETER (K903552)Concord Protex1991-01-02
TRACH-EZE (K903740)Sorex Medical1990-12-06
RESU-GARD CATHETER SUCTION (K902093)Amg Medical Equipments, Inc.1990-10-23
GENESIS INSUFFLATING CATHETER (K903669)General Medical Co.1990-09-12
STERI-CATH-DL (K902687)Concord/Portex1990-08-29
SUCTION CATHETER, STERILE (K902814)Orion Life Systems, Inc.1990-08-17
BUSSE BAC/SHIELD (K902297)Busse Hospital Disposables, Inc.1990-08-17
STERI-CATH(TM) (K902383)Concord/Portex1990-07-12
TRACHAEL SUCTION SET (K896887)Orion Life Systems, Inc.1990-04-23
SUCTION CATHETER STRAIGHT/COUDE (K896730)Unoplast A/S1990-03-30
SUCTION CATHETER KIT (K896797)Westmark, Sterile Packing Systems, Inc. (Sps)1990-02-16
MUCOUS TRAP (K896560)Westmark, Sterile Packing Systems, Inc. (Sps)1990-01-22
NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. (K896321)Superior Healthcare Group, Inc.1989-11-13
REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM (K894299)Repro-Med Systems, Inc.1989-09-22
REPRO-MED NEONATE ASPIRATION SYSTEM (K892529)Repro-Med Systems, Inc.1989-06-12
NU-TRAP SUCTION CATHETER W/MUCUS TRAP (K893462)Atheus Corp.1989-06-08
MUC-X (K893204)Island Medical1989-06-01
KENDALL CURITY SUCTION CATHETERS (K892441)The Kendal Co.1989-05-31
SUCTION CONTROL VALVE (K892343)Concord/Portex1989-04-24
NEOTECH MUCUS TRAP W/CATHETER (K890425)Neotech Products, Inc.1989-04-19
TU SUCTIONTRAP (K884944)Tulan Corp. C/O Richard Hamer Assoc.1989-02-03
KIT PAK SUCTION CATHETER KIT (K885131)Kit Pak, Inc.1989-01-09
TS1000 SUCTION TIP (K883384)M.D. Engineering, Inc.1988-11-02
RESPIRONICS SUCTIONEASY (K882017)Respironics, Inc.1988-07-14
OXY-CATH (K881428)Pulmonary Medical Devices, Inc.1988-06-10
STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407 (K875058)Busse Hospital Disposables, Inc.1988-02-12
SAFETY SHIELD SUCTION CATHETER (K873810)Ballard Medical Products1987-12-11
PEDIATRIC BUBBLE TRAP CAT. NO. B-100 (K873610)American Omni Medical, Inc.1987-11-05
TRACH CARE START KIT (K873732)Ballard Medical Products1987-10-13
TRACH CARE CATHETER (K872621)Ballard Medical Products1987-09-15
CENTURION SPECIMEN TRAP W/CATHETER (K872141)Tri-State Hospital Supply Corp.1987-08-26
JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER (K872917)American Pharmaseal Div. Ahsc1987-08-11
ORAL SUCTION CATHETER (K872283)Ballard Medical Products1987-08-03
MECONIUM SUCTION CATHETER (K871825)Concord Laboratories, Inc.1987-06-29
MMG DELEE SUCTION CATHETER W/MUCOUS TRAP (K871949)Medical Technologies of Georgia1987-06-15
MECONIUM ASPIRATOR (K871407)Intertech Resources, Inc.1987-06-15
GESCO ASPIRATOR (K870962)Gesco Intl., Inc.1987-05-22
TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 (K864535)Concord Laboratories, Inc.1987-01-06
TRACHEOBRONCHIAL SUCTION CATHETER (K864468)Sheridan Catheter Corp.1987-01-06
SUCTION CATHETER KIT (K861949)Medi-Craft , Ltd.1986-10-22
SUCTION CATHETER KIT (K863497)Welmed Systems, Inc.1986-10-06
MECONIUM SUCTION TRAP (K862181)Michael Reese Hospital and Medical Center1986-08-13
HCI MECONIUM ASPIRATOR (K862132)Hospital Concepts, Inc.1986-06-19
TRACHEOBRONCHIAL SUCTION CATHETER (K860802)Sheridan Catheter Corp.1986-04-02
ACKRAD ORAL SUCTION TUBE (K854320)Ackrad Laboratories1986-01-10
VYGON DELEE SUCTION CATHETER CODE NO 533 (K851473)Vygon Corp.1985-07-15
PENNINE DERBY YANKAUER (K852079)Pennine Medical , Ltd.1985-06-03
PENNINE SUCTION CATHETERS (K852080)Pennine Medical , Ltd.1985-06-03
TRACHEOBRONCHIAL SUCTION KITS W/CATHETERS ETO (K850864)Paco Research Corp.1985-05-02
BRONCHITRAC L (K850784)Ackrad Laboratories1985-03-25
KM PRODUCTS ASPIRATING TUBING (K850105)Km Products1985-03-21
INTERMED, INS STERILE WATER/SALINE (K842166)Intermed, Inc.1985-02-12
A FAMILY OF TRACHEOBRONCHIAL SUCTION CATHETER PROD (K850032)Paco Research Corp.1985-02-01
STERILE SALINE SOLUTION (K843797)Paco Pharmaceutical Services, Inc.1985-01-18
SUCTION CATHETER KIT (K843076)Travenol Laboratories, S.A.1984-11-20
ACT, SUCTION TIP (K842779)Edward Manougian, M.D.1984-10-12
JINOTTI OXYGEN/SUCTION CATHETER (K841425)Research Medical, Inc.1984-09-13
OXY-VAC (K842205)Medi-Tech, Inc.1984-06-25
AMER. PHARMASEAL NO TOUCH SATIN CATHET (K842198)American Pharmaseal Div. Ahsc1984-06-25
INFECTION CONTROL VALVE (K841480)Superior Plastic Products Corp.1984-04-25
TRACHEOSTOMY CLEANING TRAY (K840664)American Pharmaseal Div. Ahsc1984-03-12
DUAL PURPOSE CATHETER (K833375)Jinotti Ent Inc. Medical1984-02-10
IRRI-CATH (K833908)Portex, Inc.1984-02-04
BRONCHITRAC DF DUAL RESP/CATHETER (K833633)Ackrad Laboratories1983-12-08
ARGYLE SUCTION CATHETERS (K830709)Sherwood Medical Co.1983-03-29
SUCTION TUBES (K822724)Exco, Inc.1982-10-13
ACKRAD BRONCHITRAC (K822398)Ackrad Laboratories1982-10-04
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