Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
OMD — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
132 daysmedian FDA review time
402 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233460 | CM00622 LINC Skin Closure System (CM00622 LINC) | Connexicon Medical , Ltd. | 2024-07-15 | 266 | 0 |
| K211878 | LiquiBand XL | Advanced Medical Solutions Limited | 2022-05-23 | 336 | 0 |
| K213512 | DERMABOND PRINEO Skin Closure System | ETHICON, Inc. | 2021-12-07 | 35 | 0 |
| K191461 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | 2020-06-05 | 368 | 0 |
| K171442 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | 2017-09-25 | 132 | 0 |
| K163645 | DERMABOND PRINEO Skin Closure System | Ethicon, LLC | 2017-04-21 | 119 | 0 |
| K152490 | DERMABOND PRINEO Skin Closure System | ETHICON, Inc. | 2015-11-25 | 85 | 0 |
| K133864 | DERMABOND PRINEO SKIN CLOSURE SYSTEM | ETHICON, Inc. | 2014-03-10 | 81 | 0 |
| DEN090005 | PRINEO SKIN CLOSURE SYSTEM | Closure Medical Corp. | 2010-04-30 | 402 | 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