510(k) Report

FDA applicant

Dynarex Corp.

Brewster, NY27 decisions1986–20182 recalls

FDA records 27 decisions for Dynarex Corp. (Brewster, NY) from 1986 to 2018: 27 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and FRO (Dressing, Wound, Drug). Its devices cite 12 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Dynarex Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Dynarex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2008: 12009: 22011: 22015: 12016: 12018: 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2014: 12022: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Dynarex Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EFQGauze/Sponge, Internal4decisions
  • FRODressing, Wound, Drug3decisions
  • KMFBandage, Liquid2decisions
  • LZAPolymer Patient Examination Glove1decision
  • MUIMedia, Coupling, Ultrasound1decision
  • LYYLatex Patient Examination Glove1decision

Also: HIB (1), EZD (1), KKX (1), JOK (1), BTO (1), CBP (1).

Whose devices does it build on?

Its devices cite 12 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K092488Dynarex Sterile Lubricating JellyDynarex Corporation · 20093cite it
  • K082863Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for Gravity and Pump Use…Dynarex Corporation · 20092cite it
  • K081569Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with Chemotherapy DrugsDynarex Corporation · 20081cites it
  • K052314Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-LargeDynarex Corp. · 20051cites it
  • K012816Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414Dynarex Corp. · 20021cites it
  • K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation · 20161cites it

What has FDA decided for it lately?

  • K172266Dynarex Three-Way StopcockDynarex Corporation · 2018
  • K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation · 2016
  • K151575Dynarex Eye CupsDynarex Corporation · 2015
  • K103086Dynarex Intermittent Catheters, Male, Female, PediatricDynarex Corporation · 2011
  • K102637Dynarex Ultrasound GelDynarex Corporation · 2011
  • K092488Dynarex Sterile Lubricating JellyDynarex Corporation · 20091 recall
  • K082863Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for Gravity and Pump Use…Dynarex Corporation · 2009
  • K081569Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with Chemotherapy DrugsDynarex Corporation · 2008

All 19 as Dynarex Corp. →All 8 as Dynarex Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K092488DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250May 25, 2022Class II
  • K052743CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label…Jul 2, 2014Class II