Popper & Sons, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Popper & Sons, Inc.” (first 1984, latest 1991), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| GDM | Needle, Aspiration And Injection, Reusable | 3 | 3 |
| FCG | Biopsy Needle | 2 | 2 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Popper & Sons, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911397 | HYPODERMIC NEEDLES, SINGLE LUMEN | FCG | 1991-05-20 | 52 |
| K843830 | J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI | GDM | 1984-10-26 | 25 |
| K843690 | ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE | GDM | 1984-10-25 | 36 |
| K842406 | WESCOTT TYPE BIOPSY NEEDLE | — | 1984-08-09 | 51 |
| K841301 | GARDNER TYPE BONE MARROW NEEDLE | GAA | 1984-06-05 | 67 |
| K841300 | ANTRUM NEEDLE-WOLF TYPE | — | 1984-06-05 | 67 |
| K841299 | BIERMAN BIOPSY NEEDLE | GDM | 1984-05-02 | 33 |
| K840168 | WESTERMAN-JENSEN BIOPSY NEEDLE | FCG | 1984-03-12 | 56 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-01-02.
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 Popper & Sons, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Popper & Sons, Inc.” (first 1984, latest 1991), across 4 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 Popper & Sons, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Popper & Sons, Inc. is 52 days.
Which FDA product codes appear under Popper & Sons, Inc.?
The most frequent FDA product codes under this applicant name are GDM (Needle, Aspiration And Injection, Reusable, 3); FCG (Biopsy Needle, 2); GAA (Needle, Aspiration And Injection, Disposable, 1).
Next steps
- See all 8 Popper & Sons, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GDM, Popper & Sons, 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.