Atlas FDA

EYN

15 FDA 510(k) clearances · Product code

94 daysmedian time to decision
316 days90th percentile
15clearances measured

FDA profile

Official device name
Tray, Irrigation, Sterile
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
1992: 1 · 1993: 1 · 1994: 1 · 1999: 1 · 2001: 1 · 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
IRRIGATION TRAY (K944882)Clinical Resources, Inc.1995-01-12
IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE (K923941)American Healthcare Corp.1993-06-17
IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (K923939)American Healthcare Corp.1993-06-17
IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (K923938)American Healthcare Corp.1993-06-17
IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (K923940)American Healthcare Corp.1993-06-17
KIT PAK IRRIGATION TRAY (K900148)Kit Pak, Inc.1990-04-23
PISTON IRRIGATION TRAY (K900737)Orion Life Systems, Inc.1990-04-19
BULB IRRIGATION TRAY (K900736)Orion Life Systems, Inc.1990-04-17
CATHETER IRRIGATION TRAYS, #3300, 3310 & (K801783)The Healthcare Group Laboratories, Inc.1980-08-13
GAVAGE FEEDING SET (K792082)Medical Devices, Inc.1979-11-13
FLUID ADMINISTRATION SET FA-3160 (K791020)Burron Medical Products, Inc.1979-06-27
GREENLINE IRRIGATION TRAYS (K790607)Snyder Laboratories, Inc.1979-05-11
IRRIGATOR, BODY CAVITY (K781918)Bci, Inc.1979-02-15
IRRIGATION TRAY (K781748)Intermed, Inc.1978-12-12
TRAY, BLADDER IRRIGATION (K760047)M-C Ind., Inc.1977-03-01

Track EYN automatically

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