Atlas FDA

KYZ

41 FDA 510(k) clearances · Product code

77 daysmedian time to decision
230 days90th percentile
41clearances measured

FDA profile

Official device name
Syringe, Irrigating (Non Dental)
Device class
Class I (low risk)
Regulation
21 CFR 880.6960
Medical specialty
General Hospital
Flags
GMP exempt
Adverse events (MAUDE)
2018: 76 · 2019: 69 · 2020: 88 · 2021: 41 · 2024: 106 · 2025: 28
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
OtoSet- Ear Cleaning System (K201877)Safkan, Inc.2020-11-05
SINGLE CANNULA EXTENDED APPLICATOR (K102563)Micromedics, Inc.2011-03-15
TISSU TRANS HARVEST TUBING (K092022)Shippert Medical Technologies Corp.2009-08-17
TISSU-TRANS (K050797)Shippert Medical Technologies Corp.2005-07-13
QS DELIVERY SYSTEM (K991254)Sub-Q, Inc.1999-08-23
IRRIGATION SYRINGE KIT (K982435)Sub-Q, Inc.1998-11-06
ZEROWET SPLASHIELD (K974288)Zerowet, Inc.1998-01-29
RMI DUAL FLUID IRRIGATING SYRINGE (K964833)Research Medical, Inc.1997-02-19
MARPP PRESSURE MONITORING SYSTEM (K960725)Paradigm Medical, Inc.1996-07-15
CPR IRRIGATION TRAY (K960212)Custom Pack Reliability1996-04-01
REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION (K952406)Contour Fabricators of Florida, Inc.1995-08-07
REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER (K952407)Contour Fabricators of Florida, Inc.1995-08-07
INMAN IRRIGATION TAPERED PROBE (K933171)Inman Medical Corp.1994-04-29
SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP (K940371)Micromedics, Inc.1994-04-06
TALC DISPENSER SYRINGE (K930610)Nusurg, Inc.1993-11-04
AVITENE DISPENSER SYRINGE (K924517)Nusurg, Inc.1993-10-27
IRRIGATING BLUNT DISSECTOR (K931912)Mayaguez Medical Center1993-08-10
WELCH ALLYN EARCLEANER (K931946)Welch Allyn, Inc.1993-07-26
IRRIGATION TRAY W/ BULB SYRINGE (K924809)Customed, Inc.1993-06-07
SPLASH GUARD (K905173)E.M. Adams1991-04-25
INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM (K905365)Instrument Makar, Inc.1991-02-06
IRRICLEAR EAR IRRIGATION SYRINGE (K903759)Nortech Laboratories, Inc.1990-10-26
ZEROWET SPLASHIELD (K900208)Zerowet Splashield1990-09-04
GRAVITY ASSIST (K902854)Instrument Makar, Inc.1990-08-29
IRRIGATION TRAY (K896800)Westmark, Sterile Packing Systems, Inc. (Sps)1990-05-24
STRYKER TRAUMA TRAY (K894470)Stryker Corp.1989-08-18
STERILE IRRIGATION TRAYS (K890728)Cypress Medical Products, Ltd.1989-06-16
EAR IRRIGATION SET 101 (EARIGATOR) (K884786)Physicians Supply Co.1989-04-26
JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE (K884749)Johnson & Johnson Patient Care, Inc.1988-12-15
IRRIGATION KIT (K883506)L H M Ent., Inc.1988-12-13
SURGICAL SEALANT APPLICATOR (K883338)Micromedics, Inc.1988-08-23
SURGICAL SEALANT DISPENSER (SSD) (K881020)Micromedics, Inc.1988-03-25
CLEAN-FLUSH (K830572)Burron Medical Products, Inc.1983-03-17
SYRINGE IRRIGATING (K821530)Medcare Disp Products, Inc.1982-05-28
STERILE IRRIGATING SYRINGES, KITS,TRAY (K813027)Welcon, Inc.1981-11-20
SYRINGE, ENT (K810251)Megaplast, Inc.1981-03-11
IRRIJET (K810209)Ackrad Laboratories1981-02-17
IRRIGATION SET W/BULB SYRINGE (K803200)Walpak Co.1981-01-21
SAPCRILL THERMODETECT BREAST SCANNER DEV (K801573)California Cardiac Systems, Inc.1980-09-09
60CC IRRIGATING SYRINGE, PISTON TYPE, (K791998)Waz Industries, Inc.1979-10-26
IRRIGATION CAP (K780794)Travenol Laboratories, S.A.1978-07-27

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