Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pilling Weck Group — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
70 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971334 | PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR | Pilling Weck Group | 1997-06-11 | 62 | 0 |
| K965176 | PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS | Pilling Weck Group | 1997-03-04 | 70 | 0 |
| K964450 | SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT | Pilling Weck Group | 1997-01-10 | 65 | 0 |
| K964123 | REUSABLE TROCAR WITH SLEEVE (COMMON) | Pilling Weck Group | 1996-12-12 | 58 | 0 |
| K963815 | REUSABLE TROCAR WITH SLEEVE (COMMON) | Pilling Weck Group | 1996-11-05 | 43 | 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