Dukal LLC
Ronkonkoma, NY, US
DUKAL LLC appears in FDA device records in Ronkonkoma, NY. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Dukal LLC between 2012 and 2026. The busiest year on record is 2022, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2021 | 2 |
| 2022 | 3 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252823 | Dukal Crepe Paper Sterilization Wrap | FRG | Substantially Equivalent | |
| K233262 | Dukal SMS Sterilization Wrap | FRG | Substantially Equivalent | |
| K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective Gown | QPC | Substantially Equivalent | |
| K210321 | Dukal Corporation Level 1 Pediatric Face Mask | OXZ | Substantially Equivalent | |
| K203237 | Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown | FYA | Substantially Equivalent | |
| K201732 | Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On | FXX | Substantially Equivalent | |
| K201421 | Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons | FXX | Substantially Equivalent | |
| K113689 | DUKAL LUBRICATING JELLY | KMJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2435946 | 1000137528 | DUKAL LLC | 2 Fleetwood Ct., Ronkonkoma, NY 11779 US | 2026 | and 79 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHRAbsorber, Saliva, Paper
- ILSAdaptor, Hygiene
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- ITGBandage, Cast
- FQMBandage, Elastic
- FNYBasin, Emesis
- KMEBedding, Disposable, Medical
- FOBBedpan
- DXQBlood Pressure Cuff
- FYFCap, Surgical
- FMLChair, Blood Donor
- HOXChart, Visual Acuity
- EFTCleanser, Denture, Over The Counter
- KERContainer, Embedding
- EFNCotton, Roll
- FXPCover, Shoe, Operating-Room
- EHKCup, Prophylaxis
- FMADepressor, Tongue, Non-Surgical
- FRODressing, Wound, Drug
- EHZEvacuator, Oral Cavity
- FRLFiber, Medical, Absorbent
- HTDForceps
- GWXFork, Tuning
- EFQGauze/Sponge, Internal
- GDYGauze/Sponge, Internal, X-Ray Detectable
- FMEGown, Examination
- FYAGown, Surgical
- EJBHandle, Instrument, Dental
- EGZHolder, Film, X-Ray
- JOJIndicator, Physical/Chemical Sterilization Process
- KMJLubricant, Patient
- FXXMask, Surgical
- DYNMouthpiece, Saliva Ejector
- IMDPack, Hot Or Cold, Disposable
- HMPPad, Eye
- GWZPercussor
- GWYPinwheel
- FMPProtector, Skin Pressure
- JOKScissors, Medical, Disposable
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- ILISling, Arm
- HIBSpeculum, Vaginal, Nonmetal
- ILHSplint, Hand, And Components
- HOZSponge, Ophthalmic
- FOXStand, Infusion
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- FZMStool, Operating-Room
- FPXStrip, Adhesive, Closure, Skin
- EIBSyringe, Irrigating (Dental)
- EIDSyringe, Restorative And Impression Material
- KGXTape And Bandage, Adhesive
- FTYTape, Measuring, Rulers And Calipers
- EFWToothbrush, Manual
- GAXTourniquet, Nonpneumatic
- EHYTray, Impression, Preformed
- FSMTray, Surgical, Instrument
- ECBUnit, Syringe, Air And/Or Water
- IORWheelchair, Mechanical
- KGNWound Dressing With Animal-Derived Material(S)
- FRGWrap, Sterilization
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0233-2018 | BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection. | Intact carton revealed presence of shredded burn sheets | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain