Data / Medical devices / United States / Stat Medical Devices, Inc.
Stat Medical Devices, Inc.: FDA-registered device maker in North Miami Beach, FL, United States, 3 510(k) clearances
Stat Medical Devices, Inc. is registered with the FDA (registration 1058955) in North Miami Beach, FL, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 8, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1058955
- FEI number
- 1000525253
- Address
- 2056 NE 153rd St, North Miami Beach, FL, United States, 33162
- Owner or operator
- STAT MEDICAL DEVICES, INC. (9020044)
- Roles
- Specification developer
- First device listed
- November 16, 2009
- Registered through
- 2026
- Brand names listed
- ONE Drop Lancing Device, STAT Super-Fine Insulin Pen Needle Micro, STAT Super-Fine Insulin Pen Needle Standard, STAT Super-Fine Insulin Pen Needle Xtra, TRIO Lancing Device, ULTIMATE Lancing Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Specification developer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | 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 |
|---|---|---|---|---|---|---|
| September 8, 2023 | K230310 | STAT Medical Device Lancing System | QRK | Substantially Equivalent | Stat Medical Devices | accessdata.fda.gov |
| February 15, 2023 | K223815 | ONE DROP Lancing Device | QRK | Substantially Equivalent | Stat Medical Devices | accessdata.fda.gov |
| October 2, 2009 | K092016 | SUPER-FINE PEN NEEDLE | FMI | Substantially Equivalent | Stat Medical Devices, 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 |
|---|---|---|---|---|---|---|
| May 29, 2009 | 52159 | Not yet classified | Terminated | Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously. | Stat Pen Needles with silicone coating have not been cleared by FDA for use with silicone coating which could significantly affect the safety and effectiveness of the device. | accessdata.fda.gov |
Compare with other makers
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Needle, Hypodermic, Single Lumen
Updated September 8, 2023. 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.