Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GCL · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951197 | FE-24X, FIBER ESOPHAGOSCOPE | Pentax Precision Instrument Corp. | 1995-05-30 | 75 | 0 |
| K951198 | FE-34TH, FIBER ESOPHAGOSCOPE | Pentax Precision Instrument Corp. | 1995-05-30 | 75 | 0 |
| K934510 | 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD | Phx Technologies Corp. | 1994-02-17 | 156 | 0 |
| K922086 | BARD BIOPSY FORCEPS | C.R. Bard, Inc. | 1992-10-30 | 179 | 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