Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pilling Weck Surgical · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
128 daysmedian FDA review time
415 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992476 | PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS | Pilling Weck Surgical | 2000-09-13 | 415 | 0 |
| K992174 | PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP | Pilling Weck Surgical | 2000-03-23 | 269 | 0 |
| K990935 | JACKSON ESOPHAGEAL DILATOR | Pilling Weck Surgical | 1999-05-17 | 59 | 0 |
| K990561 | OPTICAL FORCEPS | Pilling Weck Surgical | 1999-05-14 | 81 | 0 |
| K982128 | SHIKANI-FRENCH SPEAKING VALVE | Pilling Weck Surgical | 1998-10-23 | 128 | 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