Retractable Technologies, Inc.
Little Elm, TX, US
RETRACTABLE TECHNOLOGIES, INC. appears in FDA device records in Little Elm, TX. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Retractable Technologies, Inc. between 1995 and 2021. The busiest year on record is 1997, with 3. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1997 | 3 |
| 1998 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2011 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202325 | EasyPoint Blood Collection Plus | JKA | Substantially Equivalent | |
| K133635 | EASYPOINT NEEDLE | FMI | Substantially Equivalent | |
| K122355 | VANISHPOINT BLOOD COLLECTION SET | JKA | Substantially Equivalent | |
| K112512 | VANISHPOINT BLOOD COLLECTION SET | FPA | Substantially Equivalent | |
| K101708 | PATIENT SAFE LUER CAP | FMF | Substantially Equivalent | |
| K081420 | VANISHPOINT I.V. CATHETER | FOZ | Substantially Equivalent | |
| K072654 | PATIENT SAFE SYRINGE | FMF | Substantially Equivalent | |
| K051355 | VANISHPOINT I.V. CATHETER | FOZ | Substantially Equivalent | |
| K980069 | VANISHPOINT SYRINGE | MEG | Substantially Equivalent | |
| K973301 | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE | MEG | Substantially Equivalent | |
| K971763 | BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER | FMI | Substantially Equivalent | |
| K970803 | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE | MEG | Substantially Equivalent | |
| K946219 | POP-N-LOK SYRINGE | MEG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1647137 | 1000306068 | RETRACTABLE TECHNOLOGIES, INC. | 511 Lobo Ln, Little Elm, TX 75068 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1293-2024 | EasyPoint Needle, 25G x 5/8", REF: 82091 | The needle cannula of a retractable needle may detach from the needle holder in the patient. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain