Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Encision, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
270 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201018 | Encision AEM enTouch 2X Scissor | Encision, Inc. | 2020-07-15 | 89 | 0 |
| K140006 | ENDOSHIELD BURN PROTECTION SYSTEM | Encision, Inc. | 2014-06-16 | 165 | 0 |
| K131949 | AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES | Encision, Inc. | 2013-08-26 | 60 | 0 |
| K122383 | EM3 AEM MONITOR AEM CONNECTORS | Encision, Inc. | 2013-01-10 | 157 | 0 |
| K122580 | AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM | Encision, Inc. | 2012-11-09 | 78 | 0 |
| K093622 | AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES90 | Encision, Inc. | 2010-08-20 | 270 | 0 |
| K100711 | SUCTION IRRIGATION ELECTRODES AND ADAPTERS | Encision, Inc. | 2010-06-09 | 89 | 5 |
| K091074 | AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES | Encision, Inc. | 2009-08-17 | 125 | 9 |
| K090979 | DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES | Encision, Inc. | 2009-05-28 | 51 | 0 |
| K072789 | DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES | Encision, Inc. | 2007-10-19 | 18 | 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