# Strukmyer Medical, LLC

- Location (FDA's records): Mesquite, TX
- FDA decisions: 3 (2016–2023): 3 510(k) clearances
- Names in FDA's records: Strukmyer Medical, LLC (2); Strukmyer Medical (1)
- Product codes: KGN (2), FRO (1)
- 510(k) review time since 2016: median 84 days, against 194 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Human Biosciences, Inc.: 1 (https://510kreport.com/company/human-biosciences)
- Biocore Medical Technologies, Inc.: 1 (https://510kreport.com/company/biocore-medical-technologies)
- Nurse Assist, Inc.: 1 (https://510kreport.com/company/nurse-assist)

## Firms that cite its devices most
- Huizhou Foryou Medical Devices Co., Ltd.: 1 (https://510kreport.com/company/huizhou-foryou-medical-devices)
- Anexa Biomedical, Inc.: 1 (https://510kreport.com/company/anexa-biomedical)
- Roosin Medical Co., Ltd.: 1 (https://510kreport.com/company/roosin-medical)
- Ventris Medical: 1 (https://510kreport.com/company/ventris-medical)

## Its most-cited devices
- K171645: CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle (2017), cited by 3
- K161311: USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles (2016), cited by 1

## Recent decisions
- K232758: Comatryx OTC (Dec 1, 2023)
- K171645: CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle (Jul 25, 2017)
- K161311: USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles (Aug 29, 2016)

Source page: https://510kreport.com/company/strukmyer-medical