Data / Medical devices / United States / Retractable Technologies, Inc.
Retractable Technologies, Inc.: FDA-registered device maker in Little Elm, TX, United States, 11 510(k) clearances
Retractable Technologies, Inc. is registered with the FDA (registration 1647137) in Little Elm, TX, United States. It lists 6 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 9, 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
- 1647137
- FEI number
- 1000306068
- Address
- 511 Lobo Ln, Little Elm, TX, United States, 75068
- Owner or operator
- RETRACTABLE TECHNOLOGIES, INC. (9010273)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 8, 2007
- Registered through
- 2026
- Brand names listed
- EasyPoint Blood Collection Plus, EasyPoint Needle, Patient Safe Luer Cap, Patient Safe Syringe, VanishPoint Blood Collection Set, VanishPoint Blood Collection Tube Holder, VanishPoint IV Catheter, VanishPoint Syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 9, 2021 | K202325 | EasyPoint Blood Collection Plus | JKA | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| June 17, 2014 | K133635 | EASYPOINT NEEDLE | FMI | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| August 23, 2013 | K122355 | VANISHPOINT BLOOD COLLECTION SET | JKA | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| February 24, 2011 | K101708 | PATIENT SAFE LUER CAP | FMF | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| November 7, 2008 | K081420 | VANISHPOINT I.V. CATHETER | FOZ | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| December 14, 2007 | K072654 | PATIENT SAFE SYRINGE | FMF | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| February 12, 1998 | K980069 | VANISHPOINT SYRINGE | MEG | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| November 7, 1997 | K973301 | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE | MEG | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| August 26, 1997 | K971763 | BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER | FMI | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| May 29, 1997 | K970803 | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE | MEG | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| December 28, 1995 | K946219 | POP-N-LOK SYRINGE | MEG | Substantially Equivalent | Retractable Technologies, 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, 2024 | 93981 | Class II | Ongoing | EasyPoint Needle, 25G x 5/8", REF: 82091 | The needle cannula of a retractable needle may detach from the needle holder in the patient. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Antistick
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Set, Administration, Intravascular
Updated March 14, 2024. 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.