Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pilling Weck, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
126 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990547 | PILLING WECK SURGICAL Y STENT FORCEPS | Pilling Weck, Inc. | 1999-04-27 | 64 | 0 |
| K974250 | VERSASTAT MULTIPOLAR SCISSORS AND CABLES | Pilling Weck, Inc. | 1998-02-11 | 90 | 0 |
| K962771 | BURKE CONGENITAL THORACOSCOPY INSTRUMENTS | Pilling Weck, Inc. | 1996-11-19 | 126 | 0 |
| K945520 | HEMOCLIP ECOSYSTEM | Pilling Weck, Inc. | 1995-01-27 | 78 | 0 |
| K944552 | PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP | Pilling Weck, Inc. | 1994-11-07 | 52 | 0 |
| K943719 | VISISTAT STAPLER | Pilling Weck, Inc. | 1994-08-24 | 23 | 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