Plastafil, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Plastafil, Inc.” (first 1984, latest 1984), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 130 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 |
|---|---|---|---|
| FZX | Guide, Surgical, Instrument | 2 | 2 |
| HTX | Rongeur | 2 | 2 |
| HWQ | Passer | 2 | 2 |
| GAD | Retractor | 1 | 1 |
| HCF | Instrument, Ligature Passing And Knot Tying | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| HTW | Bit, Drill | 1 | 1 |
| HWA | Impactor | 1 | 1 |
| HXG | Tamp | 1 | 1 |
| HXN | Applier, Cerclage | 1 | 1 |
Review panels
Most recent Plastafil, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841621 | BACK RADIUS CUTTER | HTX | 1984-09-20 | 154 |
| K841620 | FRONT RADIUS CUTTER | HTX | 1984-09-20 | 154 |
| K841629 | DRILL BIT | HTW | 1984-08-27 | 130 |
| K841627 | MALLET | HWA | 1984-08-27 | 130 |
| K841626 | PUNCH | HXG | 1984-08-27 | 130 |
| K841625 | HOOK | GAD | 1984-08-27 | 130 |
| K841624 | PROBE | HRX | 1984-08-27 | 130 |
| K841618 | THREADING TUBE | FZX | 1984-08-27 | 130 |
| K841617 | STROVER HOOK | HCF | 1984-08-27 | 130 |
| K841628 | WIRE | HXN | 1984-07-23 | 95 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Plastafil, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Plastafil, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Plastafil, Inc.” (first 1984, latest 1984), across 10 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 Plastafil, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Plastafil, Inc. is 130 days.
Which FDA product codes appear under Plastafil, Inc.?
The most frequent FDA product codes under this applicant name are FZX (Guide, Surgical, Instrument, 2); HTX (Rongeur, 2); HWQ (Passer, 2).
Next steps
- See all 13 Plastafil, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FZX, Plastafil, 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.