Premium Plastics, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Premium Plastics, Inc.” (first 1977, latest 1995), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FNY | Basin, Emesis | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
| LRQ | Tracheostomy And Nasal Suctioning Kit | 1 | 1 |
Review panels
- General Hospital (4)
- General and Plastic Surgery (3)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
Most recent Premium Plastics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953226 | PULM O2 SUCTION CATHETER TRAYS | BSY | 1995-08-08 | 33 |
| K950851 | GENT-L-KARE TRACHEOSTOMY TRAYS | LRQ | 1995-06-21 | 117 |
| K950850 | GENT-L-KARE LACERATION TRAYS | FRG | 1995-03-14 | 18 |
| K943740 | ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) | FMI | 1994-12-14 | 134 |
| K890107 | GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT | FRO | 1989-10-24 | 286 |
| K893135 | GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER | JOL | 1989-06-22 | 58 |
| K850285 | GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY | KOD | 1985-02-28 | 36 |
| K800440 | STERILE SPONGE BOWLS | FNY | 1980-04-29 | 61 |
| K771448 | STERILE SUTURE REMOVAL KIT | KDD | 1977-09-06 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Premium Plastics, 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.
- Premium Plus International Limited (4 510(k)s)
- Premium Plus (Dongguan) Limited (3 510(k)s)
- Premium Fit (1 510(k)s)
- Premium Medical Technology, LLC (1 510(k)s)
- Premium Source Merchandising (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Premium Plastics, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Premium Plastics, Inc.” (first 1977, latest 1995), across 9 product codes in 4 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 Premium Plastics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Premium Plastics, Inc. is 58 days.
Which FDA product codes appear under Premium Plastics, Inc.?
The most frequent FDA product codes under this applicant name are BSY (Catheters, Suction, Tracheobronchial, 1); FMI (Needle, Hypodermic, Single Lumen, 1); FNY (Basin, Emesis, 1).
Next steps
- See all 9 Premium Plastics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSY, Premium Plastics, 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.