# Dynarex Corp.

- Location (FDA's records): Brewster, NY
- FDA decisions: 27 (1986–2018): 27 510(k) clearances
- Names in FDA's records: Dynarex Corp. (19); Dynarex Corporation (8)
- Product codes: EFQ (4), FRO (3), KMF (2), LZA (1), MUI (1), LYY (1), HIB (1), EZD (1), KKX (1), JOK (1), BTO (1), CBP (1)
- Predicates its devices cite: 12 (0 its own); citations of its devices by later devices: 9 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Chester Labs, Inc.: 2 (https://510kreport.com/company/chester-labs)
- Shijiazhuang Tillotson Rubber Products Co., Ltd.: 1 (https://510kreport.com/company/shijiazhuang-tillotson-rubber-products)
- Dukal Corp.: 1 (https://510kreport.com/company/dukal)
- Coloplast Manufacturing Us, LLC: 1 (https://510kreport.com/company/coloplast-manufacturing-us)
- Gel-Lite, LLC: 1 (https://510kreport.com/company/gel-lite)
- Invotec International, Inc.: 1 (https://510kreport.com/company/invotec-international)
- Eagle Health Supplies: 1 (https://510kreport.com/company/eagle-health-supplies)
- Elcam Medical Acal: 1 (https://510kreport.com/company/elcam-medical-acal)

## Firms that cite its devices most
- Roosin Medical Co., Ltd.: 1 (https://510kreport.com/company/roosin-medical)
- Acta Medical, LLC: 1 (https://510kreport.com/company/acta-medical)
- Generica Medical International, Inc.: 1 (https://510kreport.com/company/generica-medical-international)
- Depalt, Inc.: 1 (https://510kreport.com/company/depalt)
- Noble Fiber Technologies, Inc.: 1 (https://510kreport.com/company/noble-fiber-technologies)
- Jianerkang Medical Dressing Company: 1 (https://510kreport.com/company/jianerkang-medical-dressing)
- Dipped Products (Thailand), Ltd.: 1 (https://510kreport.com/company/dipped-products-thailand)
- Sion Biotext Medical, Ltd.: 1 (https://510kreport.com/company/sion-biotext-medical)

## Its most-cited devices
- K092488: Dynarex Sterile Lubricating Jelly (2009), cited by 3
- K082863: Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for Gravity and Pump Use (1000ML) (2009), cited by 2
- K081569: Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with Chemotherapy Drugs (2008), cited by 1
- K052314: Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large (2005), cited by 1
- K012816: Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414 (2002), cited by 1
- K152970: Dynarex Xeroform Petrolatum Dressing (2016), cited by 1

## Recent decisions
- K172266: Dynarex Three-Way Stopcock (Mar 14, 2018)
- K152970: Dynarex Xeroform Petrolatum Dressing (Oct 3, 2016)
- K151575: Dynarex Eye Cups (Sep 1, 2015)
- K103086: Dynarex Intermittent Catheters, Male, Female, Pediatric (Jun 7, 2011)
- K102637: Dynarex Ultrasound Gel (Feb 16, 2011)
- K092488: Dynarex Sterile Lubricating Jelly (Dec 18, 2009)
- K082863: Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for Gravity and Pump Use (1000ML) (Jan 9, 2009)
- K081569: Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with Chemotherapy Drugs (Sep 12, 2008)

Source page: https://510kreport.com/company/dynarex