Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spencer Fillmore · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130757 | KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRAN | Spencer Fillmore | 2014-04-03 | 379 | 0 |
| K123912 | KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE AP | Spencer Fillmore | 2013-05-14 | 146 | 0 |
| K123941 | KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLIND | Spencer Fillmore | 2013-04-30 | 131 | 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