Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neothermia Corp. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
15 daysmedian FDA review time
243 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041347 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | Neothermia Corp. | 2004-06-04 | 15 | 0 |
| K033427 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | Neothermia Corp. | 2003-11-10 | 13 | 0 |
| K023413 | MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM | Neothermia Corp. | 2002-11-08 | 28 | 0 |
| K022296 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | Neothermia Corp. | 2002-07-30 | 14 | 0 |
| K021577 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | Neothermia Corp. | 2002-05-29 | 15 | 0 |
| K020031 | EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777 | Neothermia Corp. | 2002-03-27 | 82 | 0 |
| K003190 | EN BLOC BIOPSY SYSTEM | Neothermia Corp. | 2001-06-11 | 243 | 11 |
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