Atlas FDA

BYY

24 FDA 510(k) clearances · Product code

51 daysmedian time to decision
84 days90th percentile
24clearances measured

FDA profile

Official device name
Tube, Aspirating, Flexible, Connecting
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6740
Medical specialty
General Hospital
Adverse events (MAUDE)
2009: 4 · 2016: 20 · 2017: 34 · 2018: 12 · 2019: 18 · 2020: 23
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
VITAFLOW SUCTION/ASPIRATION TUBING SET (K960616)Vital Concepts, Inc.1996-05-06
CONNECTING TUBING (K960218)Custom Pack Reliability1996-03-28
MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL (K955149)Bio-Medical Devices, Inc.1996-01-24
MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR (K955151)Bio-Medical Devices, Inc.1996-01-24
MAXI-FLOW (K955150)Bio-Medical Devices, Inc.1996-01-23
WILTEK IRRIGAITON/ASPIRATION TUBE SET (K922989)Wiltek Medical, Inc.1994-02-15
GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) (K911586)Megadyne Medical Products, Inc.1991-07-02
STERILE SUCTION TUBING SET (K901761)Acacia Laboratories, Inc.1990-05-07
VAN DELLEN ASPIRATING TUBING (K873463)Van Dellen, Ltd.1987-11-23
EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN (K853296)Parexel Intl. Corp.1985-08-15
PHARMA-PLAST CONNECTING TUBE TYPE SUCT- (K843470)Zimmar Consulting , Ltd.1984-11-16
FLEX BUBBLE TUBING (K832865)Sheridan Catheter Corp.1983-09-29
DYNACOR CONNECTING TUBING (K832398)Medline Industries, Inc.1983-08-24
PLASTIC TUBING CONNECTORS (K831920)Polymer Technology Corp.1983-07-19
MGN CONDUCTIVE CONNECTING TUBE, STERILE (K821703)Mgn Medical Manufacturing, Inc.1982-06-22
PLASTIC CONNECTORS (K820371)American Pharmaseal Div. Ahsc1982-04-01
AM. PH. STERILE PLASTIC CONNECTING TUBES (K820412)American Pharmaseal Div. Ahsc1982-03-31
CONNECTING TUBE (K813228)Northern Medical Industries1981-11-27
MGN CONNECTING TUBE (K811541)Mgn Medical Manufacturing, Inc.1981-06-18
ABCO CONNECTING TUBES PRECUT LENGTHS (K800235)Abco Dealers, Inc.1980-02-26
SUCTION CONNECTING TUBING (K790420)Snyder Laboratories, Inc.1979-04-23
YANKAUER & POODLE SUCTION INSTRUMENTS (K790419)Snyder Laboratories, Inc.1979-04-23
BUBBLE SUCTION TUBING (K780724)Davol, Inc.1978-06-02
FLEXIBLE TIP ASPIRATING TUBES (K761079)Pilling Co.1976-12-09

Track BYY automatically

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