Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Emcision , Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
212 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180165 | Habib EndoHPB | Emcision , Ltd. | 2018-03-20 | 57 | 0 |
| K161305 | Habib EUS RFA | Emcision , Ltd. | 2016-07-07 | 58 | 0 |
| K150029 | Habib EUS RFA | Emcision , Ltd. | 2015-06-24 | 167 | 0 |
| K083292 | HABIB ENDOHPB | Emcision , Ltd. | 2009-06-10 | 212 | 1 |
| K080717 | HABIB HEXABLATE 10 | Emcision , Ltd. | 2008-03-27 | 14 | 0 |
| K073687 | HABIB LAPAROSCOPIC HEXABLATE | Emcision , Ltd. | 2008-01-09 | 12 | 0 |
| K072383 | HABIB ENDOBLATE | Emcision , Ltd. | 2007-11-29 | 97 | 0 |
| K072126 | HABIB VESEAL | Emcision , Ltd. | 2007-10-02 | 61 | 0 |
| K071103 | HABIB HEXABLATE | Emcision , Ltd. | 2007-06-27 | 69 | 0 |
| K051420 | HABIB 4X | Emcision , Ltd. | 2005-08-15 | 75 | 3 |
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