Retractable Technologies, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Retractable Technologies, Inc.” (first 1995, latest 2021), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 122 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 385 |
| 2014 | 1 | 203 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 235 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Retractable Technologies, Inc. took a median 235 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 178 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MEG | Syringe, Antistick | 4 | 4 |
| FMF | Syringe, Piston | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Review panels
- General Hospital (11)
- Clinical Chemistry (2)
Most recent Retractable Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202325 | EasyPoint Blood Collection Plus | JKA | 2021-04-09 | 235 |
| K133635 | EASYPOINT NEEDLE | FMI | 2014-06-17 | 203 |
| K122355 | VANISHPOINT BLOOD COLLECTION SET | JKA | 2013-08-23 | 385 |
| K112512 | VANISHPOINT BLOOD COLLECTION SET | FPA | 2011-10-20 | 51 |
| K101708 | PATIENT SAFE LUER CAP | FMF | 2011-02-24 | 252 |
| K081420 | VANISHPOINT I.V. CATHETER | FOZ | 2008-11-07 | 171 |
| K072654 | PATIENT SAFE SYRINGE | FMF | 2007-12-14 | 85 |
| K051355 | VANISHPOINT I.V. CATHETER | FOZ | 2005-09-23 | 122 |
| K980069 | VANISHPOINT SYRINGE | MEG | 1998-02-12 | 35 |
| K973301 | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE | MEG | 1997-11-07 | 66 |
3 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-02-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
RETRACTABLE TECHNOLOGIES INC (RVP): EDGAR filings, CIK 946563. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Retractable Technologies, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Retractable Technologies, Inc.” (first 1995, latest 2021), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Retractable Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Retractable Technologies, Inc. is 122 days.
Which FDA product codes appear under Retractable Technologies, Inc.?
The most frequent FDA product codes under this applicant name are MEG (Syringe, Antistick, 4); FMF (Syringe, Piston, 2); FMI (Needle, Hypodermic, Single Lumen, 2).
Next steps
- See all 13 Retractable Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MEG, Retractable Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.