# Ultimed, Inc.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 10 (2000–2021): 10 510(k) clearances
- Names in FDA's records: Ultimed, Inc. (8); Ultimed Incorporated (2)
- Product codes: FMI (3), FMF (3), MMK (2), MEG (2)
- Predicates its devices cite: 14 (5 its own); citations of its devices by later devices: 10 (5 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
- Becton, Dickinson & CO: 3 (https://510kreport.com/company/becton-dickinson)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 3 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Sherwood Medical Co.: 2 (https://510kreport.com/company/sherwood-medical)
- Daejin Tech Medical Manufacturing Co., Ltd.: 1 (https://510kreport.com/company/daejin-tech-medical-manufacturing)

## Firms that cite its devices most
- Ulti-Med Intl., Inc.: 1 (https://510kreport.com/company/ulti-med-intl)
- Feel Tech: 1 (https://510kreport.com/company/feel-tech)
- Shina Corp.: 1 (https://510kreport.com/company/shina)
- Chirana T. Injecta: 1 (https://510kreport.com/company/chirana-t-injecta)
- Facet Technologies, LLC: 1 (https://510kreport.com/company/facet-technologies)

## Its most-cited devices
- K994230: Ulticare Disposable Syringe (2000), cited by 2
- K080600: Ultimed Ulticare Safety Syringe (2008), cited by 2
- K100812: Ulticare Disposable Pen Needles (2010), cited by 2
- K213407: UltiCare Disposable Pen Needles (2021), cited by 1
- K033794: Ulticare Disposable Syringe 3 ML/CC (2003), cited by 1
- K062702: Ulticare Disposable Syringes and Needles (2006), cited by 1

## Recent decisions
- K213407: UltiCare Disposable Pen Needles (Dec 16, 2021)
- K140949: Ulticare Safety Syringe with Removable Needle (Feb 9, 2015)
- K100812: Ulticare Disposable Pen Needles (Jun 3, 2010)
- K080600: Ultimed Ulticare Safety Syringe (Jun 25, 2008)
- K081449: Ultiguard Home Insulin Pen Needle Dispenser and Sharps Container (Jun 3, 2008)
- K062702: Ulticare Disposable Syringes and Needles (Nov 29, 2006)
- K050464: Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2 (May 11, 2005)
- K033794: Ulticare Disposable Syringe 3 ML/CC (Dec 30, 2003)

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