Atlas FDA

KYG

40 FDA 510(k) clearances · Product code

76 daysmedian time to decision
191 days90th percentile
40clearances measured

FDA profile

Official device name
Device, Irrigation, Ocular Surgery
Device class
Class I (low risk)
Regulation
21 CFR 886.4360
Medical specialty
Ophthalmic
Adverse events (MAUDE)
2021: 19 · 2022: 20 · 2023: 23 · 2024: 90 · 2025: 73 · 2026: 48
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
MED-LOGICS DISPOSABLE ALK TUBING (K010353)Med-Logics, Inc.2001-04-27
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 (K003036)Retinalabs.Com2000-12-22
BLADEWORKS DISPOSABLE ALK TUBING (K993591)Blade Works, Inc.1999-12-28
SOVEREIGN CATARACT EXTRACTION SYSTEM (K981116)Allergan, Inc.1998-05-19
EYE IRRIGATOR MODEL #2020 (K980647)Eye-Deal Ocular Safety Products, Inc.1998-05-15
MOISTAIR FLUID AIR TUBING SET (K974561)American Medical Devices, Inc.1998-02-19
ML DISPOSABLE ALK TUBING (K971173)Med-Logics, Inc.1997-05-22
HEDGES CORNEAL WETTING PAK (K970161)Hedges Cwp, Inc.1997-03-25
D.O.R.C. VFI/VFE SYSTEM (K954842)Dutch Ophthalmic USA, Inc.1996-04-15
DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (K945171)Boston Surgical Products, Inc.1995-02-08
PEREGRINE PIC MINIPULATOR (K940392)Peregrine Surgical , Ltd.1994-08-23
I/V POLE (K935226)Optical Micro Systems, Inc.1994-02-16
ELECTRIC I/V POLE OR EIVP2 (K935003)Optical Micro Systems, Inc.1994-01-25
MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE (K925921)Site Microsurgical Systems, Inc.1993-12-06
AUTOPOLE REGULATOR SYSTEM (K924999)Escalon Trek Medical1992-12-24
INFINITY MICRO IRRIGATOR (K924052)Infinity Surgical Technology, Inc.1992-12-23
MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS (K922996)Chiron Vision Corp.1992-07-27
LEWICKY O.R.S. TUBING (K922180)O.R. Specialties, Inc.1992-07-02
AQUEOUS PARACENTESIS PIPET (K915808)Visitec Co.1992-03-19
GRIESHABER AIR/FLUID TUBING SET (K914587)Grieshaber & Co.1992-01-23
SITE DIAPHRAGM CASSETTE (K904186)Site Microsurgical Systems, Inc.1990-11-21
B & B I/A HANDPIECE (K881517)B&B Medical Assoc., Inc.1988-08-22
INFUSION HANDLE (K881518)B&B Medical Assoc., Inc.1988-08-22
ALCON SITE(R)-COMPATIBLE CASSETTE (K881682)Alcon Laboratories1988-07-01
UNI-PORT (K880543)Surgeon Surgical Instrumentation, Inc.1988-07-01
MORGAN THERAPEUTIC LENS (K871454)Mortan, Inc.1987-06-19
MULTI-SPIKE (K861203)Surgeon Surgical Instrumentation, Inc.1986-04-28
BACSTOP FILTER IRRIGATION SUPPLY KIT (K860544)Staar Surgical Co.1986-04-04
ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) (K861013)Ameritek, Inc.1986-03-31
VISITEC IRRIGATION CONTROL SYSTEM (K853243)Visitec Co.1985-09-11
OPERAID DISPOS. IRRIGATING KNIFE (K845039)Jedmed Instrument Co.1985-03-05
OPERAID NUCLEUS (K841807)Jedmed Instrument Co.1984-11-21
ELECATH HEPARIN COATED THERMAL DILUTION (K832787)Electro-Catheter Corp.1983-10-04
MICRO SURGICAL HANDLE (K831996)Visitec Co.1983-07-12
LENS (K821897)Mortan, Inc.1983-01-05
ASPIRATOR/IRRIGATOR OR I/A UNIT (K820889)Mid Laboratories, Inc.1982-05-05
DISPOSABLE TUBING SETS (K820680)Innovative Surgical Products, Inc.1982-04-09
INTRAJECT (K802332)General Medical Engineering Corp.1980-12-22
NU-VISION DISP. OPHTHALMIC DRESSING TRAY (K801822)Summit Optics, Inc.1980-09-30
NALGENE EMERGENCY EYE WASH (K760820)Nagle Co.1976-10-20

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