Dynarex Corp.
Middletown, NY, US
DYNAREX CORP. appears in FDA device records in Middletown, NY. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 27 510(k) clearances for Dynarex Corp. between 1986 and 2018. The busiest year on record is 1986, with 3. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 3 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 1 |
| 1993 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2001 | 1 |
| 2002 | 2 |
| 2005 | 2 |
| 2008 | 1 |
| 2009 | 2 |
| 2011 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172266 | Dynarex Three-Way Stopcock | FMG | Substantially Equivalent | |
| K152970 | Dynarex Xeroform Petrolatum Dressing | FRO | Substantially Equivalent | |
| K151575 | Dynarex Eye Cups | LXQ | Substantially Equivalent | |
| K103086 | DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC | EZD | Substantially Equivalent | |
| K102637 | DYNAREX ULTRASOUND GEL | MUI | Substantially Equivalent | |
| K092488 | DYNAREX STERILE LUBRICATING JELLY | KMJ | Substantially Equivalent | |
| K082863 | DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) | KNT | Substantially Equivalent | |
| K081569 | DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | |
| K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | CBP | Substantially Equivalent | |
| K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE | HIB | Substantially Equivalent | |
| K012816 | DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 | FRO | Substantially Equivalent | |
| K012957 | TOWEL DRAPE, MODELS 4409, 4410 | KKX | Substantially Equivalent | |
| K012917 | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B | HFW | Substantially Equivalent | |
| K991695 | DYNAREX NON-WOVEN SPONGE | KMF | Substantially Equivalent | |
| K991694 | DYNAREX DRAIN SPONGE | KMF | Substantially Equivalent | |
| K983348 | DYNAREX TRACHEOSTOMY SPONGE | EFQ | Substantially Equivalent | |
| K960388 | DYNAREX NON-WOVEN SPONGE | EFQ | Substantially Equivalent | |
| K951660 | DYNAREX GAUZE SPONGE | EFQ | Substantially Equivalent | |
| K933308 | DYNAREX GAUZE SPONGE OR PADS | EFQ | Substantially Equivalent | |
| K922843 | DYNAREX SUCTION CATHETERS & KITS | BSY | Substantially Equivalent | |
| K894686 | POWDER-FREE VINYL EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K893334 | PREPOWDERED VINYL EXAM GLOVES | LYZ | Substantially Equivalent | |
| K891586 | ORAL AIRWAY | CAE | Substantially Equivalent | |
| K882567 | SKINCOTE | FRO | Substantially Equivalent for Some Indications | |
| K855130 | TRACHEOSTOMY CARE KIT | BTO | Substantially Equivalent | |
| K855132 | SHAVE PREP TRAY | MDM | Substantially Equivalent | |
| K855131 | SUTURE REMOVAL KIT | JOK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2431014 | 2431014 | DYNAREX CORP. | 11 Dynarex Drive, Middletown, NY 10941 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAEAirway, Oropharyngeal, Anesthesiology
- KMFBandage, Liquid
- EZDCatheter, Straight
- BSYCatheters, Suction, Tracheobronchial
- HFWClamp, Umbilical
- LXQCup, Eye
- KKXDrape, Surgical, Antimicrobial
- FRODressing, Wound, Drug
- EFQGauze/Sponge, Internal
- MDMInstrument, Manual, Surgical, General Use
- LYYLatex Patient Examination Glove
- KMJLubricant, Patient
- MUIMedia, Coupling, Ultrasound
- LZAPolymer Patient Examination Glove
- JOKScissors, Medical, Disposable
- HIBSpeculum, Vaginal, Nonmetal
- FMGStopcock, I.V. Set
- BTOTube, Tracheostomy (W/Wo Connector)
- KNTTubes, Gastrointestinal (And Accessories)
- CBPValve, Non-Rebreathing
- LYZVinyl Patient Examination Glove
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1955-2018 | Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators. | The device is equipped with a dial that has an inaccurate flow rate indicator. | Class II | Terminated | |
| Z-2057-2016 | dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection | Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton. | Class II | Terminated | |
| Z-2117-2014 | CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation. | "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers. | Class II | Terminated | |
| Z-0951-04 | 100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corporation, Orangeburg, NY 10962. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages per case. --- Device Listing # E177598. 510(k) Exempt. | Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex. | Terminated | ||
| Z-0573-03 | Ear Loop Procedure Masks With Plastic Shield, For one time use only, Glass-Free, Reorder No. 2202, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Orangeburg, NY 10962. Made in China. Product is labeled with a Latex-free symbol that states ''This product does not contain any natural rubber latex'' . A total of 50 masks are in one unit box, and 4 boxes are placed into one shipping carton/case. | Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex. | Terminated | ||
| Z-0572-03 | Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Brewster, NY 10509. Made in China. Product is labeled with a Latex-free symbol that states ''This product does not contain any natural rubber latex'' . A total of 50 masks are in one unit box, and 12 boxes are placed into one shipping carton/case. | Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain