Atlas FDA

JOL

84 FDA 510(k) clearances · Product code

87 daysmedian time to decision
308 days90th percentile
84clearances measured

FDA profile

Official device name
Catheter And Tip, Suction
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6740
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 283 · 2022: 221 · 2023: 197 · 2024: 277 · 2025: 279 · 2026: 130
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 (K051370)Baxter Healthcare Corp2005-08-12
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (K000266)Primary Care Solutions, Inc.2001-07-12
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (K000265)Primary Care Solutions, Inc.2001-07-12
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION (K003402)Welcon, Inc.2001-05-01
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (K994321)Automatic Liquid Packaging, Inc.2000-10-25
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (K974759)Hydrox Laboratories1998-03-09
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (K974758)Hydrox Laboratories1998-03-09
STERILE SALINE FOR CATHETER CARE (K974397)Baxter Healthcare Corp1998-02-10
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (K973734)Welcon, Inc.1998-02-05
GERM TRAPPER SUCTION TUBE HOLDER (K972372)Rzv Medical Specialties, Inc.1997-12-11
CPR SUCTION CATHETER KIT (K960216)Custom Pack Reliability1996-04-15
STERILE ISOTONIC SALINE & STERILE WATER (K954442)Medcare Custom Packaging, Inc.1995-12-21
ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER (K950201)Sherwood Medical Co.1995-12-15
THORACENTESIS CATHETER (K951524)Baxter Healthcare Corp1995-07-06
CATCO THORACIC CATHETER (K945728)Catco Medical, Inc.1995-05-23
STERILE PHYSIOLOGICAL SALINE/STERILE WATER (K943661)Medcare Custom Packaging, Inc.1995-04-10
STERILE WATER (K943773)Medline Industries, Inc.1995-02-27
STERILE .9% SODIUM CHLORIDE FOR IRRATION (K943832)Orion Life Systems, Inc.1994-11-21
PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER (K943831)Orion Life Systems, Inc.1994-11-21
PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER (K943836)Orion Life Systems, Inc.1994-11-21
STERILE WATER FOR IRRIGATION (K943828)Orion Life Systems, Inc.1994-11-21
PRE-FILLED SYSRINGE W/STERILE WATER (K943829)Orion Life Systems, Inc.1994-11-21
PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION (K943830)Orion Life Systems, Inc.1994-11-21
STERILE .9% SODIUM CHLORIDE SOLUTION (K943834)Orion Life Systems, Inc.1994-11-21
SALINE FOR IRRIGATION (K932138)Rantran, Inc.1994-11-04
STERILE WATER FOR IRRATION (K943833)Orion Life Systems, Inc.1994-11-01
GERITREX STERILE SALINE SOLUTION FOR IRRIGATION (K931509)Geritrex Corp.1994-09-22
STB YANKAUER SUCKER/NOZZLE (K933762)Save-T-Breath Distributors C.C.1994-07-19
DISPOSABLE SUCTION PROBE (K942061)United States Surgical, A Division of Tyco Healthc1994-05-16
THORA-CATH (K941232)Gesco Intl., Inc.1994-05-11
STERILE WATER (K933526)Trinity Laboratories, Inc.1994-03-10
GERITREX STERILE WATER FOR IRRIGATION (K931511)Geritrex Corp.1994-02-14
VCI SUCTION/IRRIGATION TUBING SET (K934382)Vital Concepts, Inc.1994-02-01
SURGICAL SUCTION TIP (K932185)Tlc Medservices, Inc.1993-10-27
UNIVERSAL IRRIGATION & SUCTION TUBING SET (K922714)Ximed Medical Systems1993-08-03
JAIN BLOOD SHIELD (K913896)Jain Surgical Equipment, Inc.1992-03-06
ENDOTRACHEAL SUCTIONTUBE (K913876)Willowtech1992-03-06
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET (K910693)Baxter Healthcare Corp1991-10-17
THOROCENTESIS KIT (K910963)Megadyne Medical Products, Inc.1991-06-20
STERILE WATER SOLUTION CATALOG # 10000 (K904216)Superior Healthcare Group, Inc.1990-11-16
CURITY THORACENTESIS TRAY (K903569)Kendall Healthcare Products Co. Div.Of Tyco Health1990-09-07
KLEEN TEST BASIN SET (K890039)Kleen Test Products1989-10-24
SUCTION TIP (K893667)Thomson & Shelton Instrumentation Co, Inc.1989-08-21
LAPAROSCOPIC SUCTION PROBE (K893527)Dexide, Inc.1989-07-14
GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER (K893135)Premium Plastics, Inc.1989-06-22
ARROW PNEUMOTHORAX KIT, AK-01500 (K883905)Arrow Intl., Inc.1989-01-19
URESIL THORA-FLO THORACENTESIS PROCEDURE KIT (K872948)Uresil Corp.1987-11-27
APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY (K873563)Aplicare, Inc.1987-11-23
VAN DELLEN CANNULA (K873464)Van Dellen, Ltd.1987-11-23
DEKNATEL TROCAR CATHETER (K873525)Deknatel, Inc.1987-11-02
DEKNATEL THORACIC CATHETER (K873517)Deknatel, Inc.1987-11-02
VIA-GUARD (K871950)Surgimark, Inc.1987-07-23
ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT (K870572)Arrow Intl., Inc.1987-05-26
'EXMOOR' ZOELLNER SUCKER ENDS (K864937)Exmoor Plastics , Ltd.1987-03-30
HD CRYSTALINE SUCTION TIP (K860927)Hospital Disposables, Inc.1986-03-27
DEKNATEL THORACIC CATHETER (K852041)Pfizer, Inc.1985-06-17
TROCAR CATHETER (K851979)Hospital Products Group1985-06-17
IMPACT TURBO CATH (K851611)Impact Instrumentation, Inc.1985-06-05
THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE (K851385)Gesco Intl., Inc.1985-05-23
KM PRODUCTS SUCTION TIPS (K850240)Km Products1985-03-06
PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- (K843469)Zimmar Consulting , Ltd.1984-11-19
WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP (K843188)Wells Johnson Co.1984-09-20
SUCTION DEVICE-PHARYNEAL DEVICE (K840669)Lipsky-Dale Medical Products1984-06-11
SURGICAL SUCTION INSTRUMENT-REUSABLE (K840007)Lawton Surgical Instruments1984-03-06
TRACHEOSTOMY CARE TRAYS (K832880)Packaging Technologies, Inc.1983-10-31
CUSTOM KWIK SET AND/OR PAK (K832517)Norton Texas Medical Products1983-10-14
FEMORAL CANAL SUCTION TAMPON (K831999)Richards Manufacturer Co.1983-09-29
ARGYLE YANKAVER SUCTION TUBE W/CONTROL (K832027)Sherwood Medical Co.1983-08-08
SUCTION CATHETERS (K830942)Medovations, Inc.1983-04-14
METAL BACKED ACETABULAR COMPONENT (K821342)Intermedics Orthopedics1982-05-21
ARGYLE THORACIC CATHETERS (K820718)Sherwood Medical Co.1982-04-14
3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION (K820460)Superior Plastic Products Corp.1982-03-08
STERILE WATER 4OZ. (K812312)Superior Plastic Products Corp.1981-11-13
SUCTION PROBE (K803206)Bemis Health Care1981-01-21
ARGYLE UNIVERSAL POOLE SUCTION TUBE (K803187)Sherwood Medical Co.1981-01-09
MICROVAC (K801134)Progress Mankind Technology1980-05-30
MACROVAC (K801127)Progress Mankind Technology1980-05-30
C.C.-PAK (K800635)Respiratory Care, Inc.1980-04-10
ABCO SUCTION CATHETER & KITS W/GLOVE&CUP (K800234)Abco Dealers, Inc.1980-02-26
CONPHAR FINGERTIP SUCTION CONTROL (K791801)Conphar, Inc.1979-09-21
HYSTERECTOMY T DRAIN (K782027)Davol, Inc.1978-12-20
CATHETER THORACIC, AXIOM (K770983)Axiom Medical, Inc.1977-07-29
STERILE SUCTION CATHETER W/CONTROL (K770233)Chesire Laboratories1977-04-05
SUCTION KIT (K760586)Bd Becton Dickinson Vacutainer Systems Preanalytic1976-11-12

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