Plasco, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Plasco, Inc.” (first 1983, latest 1998), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | 5 | 5 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 4 | 4 |
| FCE | Enema Kit | 3 | 3 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| FPD | Tube, Feeding | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
Review panels
Most recent Plasco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980066 | CPR FILTERSHIELD | BTM | 1998-07-16 | 190 |
| K953414 | CPR MICROMASK WITH OXYGEN INLET | CBP | 1996-03-20 | 244 |
| K951483 | CPR MICROMASK | CBP | 1995-10-19 | 203 |
| K950770 | CPR MICROSHIELD II | CBP | 1995-03-10 | 17 |
| K950769 | CPR MICROMASK PLUS CATALOG NO 73-402 | CBP | 1995-03-10 | 17 |
| K943386 | CPR MICROMASK | CBP | 1995-02-21 | 223 |
| K932649 | PHARMAFEED | KPE | 1993-11-16 | 167 |
| K880337 | MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 | FCE | 1988-04-14 | 79 |
| K870623 | ENTERAL ADMINISTRATION SET | FPD | 1987-06-26 | 134 |
| K870796 | MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY | FCE | 1987-04-01 | 33 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Plasco, 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 Plasco, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Plasco, Inc.” (first 1983, latest 1998), across 7 product codes in 3 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 Plasco, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Plasco, Inc. is 82 days.
Which FDA product codes appear under Plasco, Inc.?
The most frequent FDA product codes under this applicant name are CBP (Valve, Non-Rebreathing, 5); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 4); FCE (Enema Kit, 3).
Next steps
- See all 16 Plasco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBP, Plasco, 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.