Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Popper & Sons, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
67 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911397 | HYPODERMIC NEEDLES, SINGLE LUMEN | Popper & Sons, Inc. | 1991-05-20 | 52 | 0 |
| K843830 | J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI | Popper & Sons, Inc. | 1984-10-26 | 25 | 0 |
| K843690 | ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE | Popper & Sons, Inc. | 1984-10-25 | 36 | 0 |
| K842406 | WESCOTT TYPE BIOPSY NEEDLE | Popper & Sons, Inc. | 1984-08-09 | 51 | 0 |
| K841301 | GARDNER TYPE BONE MARROW NEEDLE | Popper & Sons, Inc. | 1984-06-05 | 67 | 0 |
| K841300 | ANTRUM NEEDLE-WOLF TYPE | Popper & Sons, Inc. | 1984-06-05 | 67 | 0 |
| K841299 | BIERMAN BIOPSY NEEDLE | Popper & Sons, Inc. | 1984-05-02 | 33 | 0 |
| K840168 | WESTERMAN-JENSEN BIOPSY NEEDLE | Popper & Sons, Inc. | 1984-03-12 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda