Data / Medical devices / United States / Ulti Med, Inc.
Ulti Med, Inc.: FDA-registered device maker in De Smet, SD, United States, 15 510(k) clearances
Ulti Med, Inc. is registered with the FDA (registration 2183771) in De Smet, SD, United States. It lists 4 device types. The FDA files 15 510(k) clearances under its listings, the newest dated December 16, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183771
- Address
- 710 Fourth Street, De Smet, SD, United States, 57231
- Owner or operator
- ULTI MED, INC. (2183771)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 24, 2007
- Registered through
- 2026
- Brand names listed
- AND OTHERS, Assure ID Insulin Safety Syringes, Domesta, GOOD NEIGHBOR PHARMACY, Health Mart PHARMACY, Health Mart. PHARMACY, Life Brand, Medline and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Sharps | MMK | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 16, 2021 | K213407 | UltiCare Disposable Pen Needles | FMI | Substantially Equivalent | Ultimed Incorporated | accessdata.fda.gov |
| July 24, 2018 | K172095 | Autokeeper | FMI | Substantially Equivalent | Medexel Co.,Ltd | accessdata.fda.gov |
| February 2, 2016 | K152410 | Top Fine Pen Needle | FMI | Substantially Equivalent | Medexel Co.,Ltd | accessdata.fda.gov |
| February 9, 2015 | K140949 | ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE | MEG | Substantially Equivalent | Ultimed Incorporated | accessdata.fda.gov |
| February 25, 2014 | K133059 | INSULIN PEN NEEDLE | FMI | Substantially Equivalent | Wenzhou Beipu Science & Technology Co., Ltd. | accessdata.fda.gov |
| February 2, 2011 | K103011 | ULTICARE SAFETY INSULIN SYRINGE | MEG | Substantially Equivalent | Ulti-Med Intl., Inc. | accessdata.fda.gov |
| June 3, 2010 | K100812 | ULTICARE DISPOSABLE PEN NEEDLES | FMI | Substantially Equivalent | Ultimed, Inc. | accessdata.fda.gov |
| June 25, 2008 | K080600 | ULTIMED ULTICARE SAFETY SYRINGE | MEG | Substantially Equivalent | Ultimed, Inc. | accessdata.fda.gov |
| June 3, 2008 | K081449 | ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER | MMK | Substantially Equivalent | Ultimed, Inc. | accessdata.fda.gov |
| November 29, 2006 | K062702 | ULTICARE DISPOSABLE SYRINGES AND NEEDLES | FMF | Substantially Equivalent | Ultimed, Inc. | accessdata.fda.gov |
| May 11, 2005 | K050464 | ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 | FMI | Substantially Equivalent | Ultimed, Inc. | accessdata.fda.gov |
| December 30, 2003 | K033794 | ULTICARE DISPOSABLE SYRINGE 3 ML/CC | FMF | Substantially Equivalent | Ultimed, Inc. | accessdata.fda.gov |
| September 16, 2002 | K021983 | ULTI GUARD HOME INSULIN SYRINGE CONTAINER | MMK | Substantially Equivalent | Ultimed, Inc. | accessdata.fda.gov |
| March 24, 2000 | K994230 | ULTICARE DISPOSABLE SYRINGE | FMF | Substantially Equivalent | Ultimed, Inc. | accessdata.fda.gov |
| February 11, 1988 | K875148 | MEDICRAT, HYPODERMIC SYRINGES & NEEDLES | FMF | Substantially Equivalent | Knowltech Ind., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 5, 2010 | 54655 | Not yet classified | Terminated | Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Manufactured by UltiCare. Used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutica | UltiMed, Inc. is recalling one lot of 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe Live Better because it is mislabeled and actually contains 1/2 cc, 30 gauge x 1/2 inch U-100 insulin Syringe. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
- All makers of Container, Sharps
Updated December 16, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.