Plastic Injectors, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Plastic Injectors, Inc.” (first 1984, latest 1989), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 28 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JTC | Device, Microtiter Diluting/Dispensing | 3 | 3 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 3 | 3 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Plastic Injectors, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884781 | OPTI-POINT | HET | 1989-01-12 | 58 |
| K863423 | CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 | JTC | 1986-09-16 | 12 |
| K863374 | CODE-A-WELL SERIES 1-600, 1-625 | JTC | 1986-09-11 | 8 |
| K844058 | CODE-A-WALL SERIES 1-250 INOCULUM TRAY | — | 1984-11-13 | 26 |
| K842848 | CODE-A-WELL 350 MICROTITRATION STRIPS | JTC | 1984-09-07 | 49 |
| K841632 | CODE-A-WELL SERIES 200 PLATE | LIB | 1984-05-25 | 35 |
| K841937 | CODE-A-WELL SERIES 300 PLATE | LIB | 1984-05-22 | 11 |
| K841390 | CODE-A-WELL | LIB | 1984-05-02 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Plastic Injectors, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Plastic Engineered Products Co. (2 510(k)s)
- Plastic, Inc. (1 510(k)s)
- Plastic Applications, Inc. (1 510(k)s)
- Plastic Manufacturing and Marketing Group, Inc. (1 510(k)s)
- Plastic Materials of Puerto Rico, Inc. (1 510(k)s)
- Plastic Parts Corp. (1 510(k)s)
- Plastic Surgery Solutions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Plastic Injectors, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Plastic Injectors, Inc.” (first 1984, latest 1989), across 4 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 Plastic Injectors, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Plastic Injectors, Inc. is 28 days.
Which FDA product codes appear under Plastic Injectors, Inc.?
The most frequent FDA product codes under this applicant name are JTC (Device, Microtiter Diluting/Dispensing, 3); LIB (Device, General Purpose, Microbiology, Diagnostic, 3); HET (Laparoscope, Gynecologic (And Accessories), 1).
Next steps
- See all 8 Plastic Injectors, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JTC, Plastic Injectors, 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.