Landmark Plastics: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Landmark Plastics” (first 1976, latest 1976), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 81 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 |
|---|---|---|---|
| FNY | Basin, Emesis | 3 | 3 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 1 | 1 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
| FLK | Thermometer, Clinical Mercury | 1 | 1 |
| FMH | Container, Specimen, Sterile | 1 | 1 |
| FOB | Bedpan | 1 | 1 |
| KYX | Dispenser, Liquid Medication | 1 | 1 |
| LDR | Controller, Infusion, Intravascular, Electronic | 1 | 1 |
| LRP | Tray, Surgical | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Landmark Plastics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K760552 | THERMOMETER STAND AND DUST COVER | FLK | 1976-11-12 | 74 |
| K760548 | CARAFE AND LINER | — | 1976-11-12 | 74 |
| K760517 | CUP, DISPOSABLE MEDICINE | KYX | 1976-11-12 | 79 |
| K760497 | TRAY, SERVICE | LRP | 1976-11-12 | 81 |
| K760496 | CUP, DISPOSABLE SPECIMEN | FMH | 1976-11-12 | 81 |
| K760495 | BASIN, RECTANGULAR WASH | FNY | 1976-11-12 | 81 |
| K760494 | BASIN, ROUND WASH | FNY | 1976-11-12 | 81 |
| K760493 | DISH, SOAP | — | 1976-11-12 | 81 |
| K760492 | BASIN, LARGE OR SMALL | FNY | 1976-11-12 | 81 |
| K760490 | BEDPAN, GENERAL MEDICAL MEDI-PAK | FOB | 1976-11-12 | 81 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Landmark Plastics.
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.
- Landmark Scientific, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Landmark Plastics?
FDA lists 13 510(k) clearances under the applicant name “Landmark Plastics” (first 1976, latest 1976), across 10 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 Landmark Plastics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Landmark Plastics is 81 days.
Which FDA product codes appear under Landmark Plastics?
The most frequent FDA product codes under this applicant name are FNY (Basin, Emesis, 3); BYF (Mask, Oxygen, Low Concentration, Venturi, 1); CAT (Cannula, Nasal, Oxygen, 1).
Next steps
- See all 13 Landmark Plastics clearances with predicates and recalls
- Run predicate analysis for product code FNY, Landmark Plastics'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.