Pharma-Plast USA, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Pharma-Plast USA, Inc.” (first 1985, latest 1989), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 100 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| FMF | Syringe, Piston | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| DZM | Needle, Dental | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| LZG | Pump, Infusion, Insulin | 1 | 1 |
Review panels
- General Hospital (6)
- Anesthesiology (1)
- Clinical Chemistry (1)
- Dental (1)
Most recent Pharma-Plast USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K894371 | NIPRO SAFELET CATH | FOZ | 1989-10-25 | 100 |
| K894373 | NIPRO DENTAL NEEDLE | DZM | 1989-10-13 | 88 |
| K894374 | BLOOD DRAWING NEEDLE | FMI | 1989-09-28 | 73 |
| K894372 | NIPRO NEEDLE HOLDER | FMI | 1989-09-28 | 73 |
| K884978 | PHARMA-PLAST INSULIN INFUSION SET | LZG | 1989-06-21 | 203 |
| K871263 | MULTIPLE PHARMA-PLAST TRACHEAL TUBE | BTR | 1987-06-15 | 76 |
| K852444 | ASIK 'ONCE' SYRINGE | FMF | 1985-10-16 | 128 |
| K852443 | PHARMA-PLAST CLINIPAK | FMF | 1985-10-16 | 128 |
| K852442 | PHARMA-PLAST NEEDLE | FMI | 1985-09-20 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Pharma-Plast USA, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Pharma-Plast USA, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZG)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZG)
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.
- Pharma-Plast Intl. A/S (2 510(k)s)
- Pharma-Plast, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pharma-Plast USA, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Pharma-Plast USA, Inc.” (first 1985, latest 1989), across 6 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 Pharma-Plast USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pharma-Plast USA, Inc. is 100 days.
Which FDA product codes appear under Pharma-Plast USA, Inc.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 3); FMF (Syringe, Piston, 2); BTR (Tube, Tracheal (W/Wo Connector), 1).
Next steps
- See all 9 Pharma-Plast USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Pharma-Plast USA, 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.