Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OSP — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
302 daysmedian FDA review time
734 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190798 | LaborView™ LV1000 Wireless Electrode System | Obmedical Company | 2020-09-18 | 540 | 0 |
| K153262 | PUREtrace™ | Nemo Healthcare BV | 2017-02-07 | 455 | 0 |
| K142583 | LaborView LV1000 | Obmedical Company | 2015-01-16 | 123 | 0 |
| K140862 | MONICA NOVII WIRELESS PATCH SYSTEM | Monica Healthcare, Ltd. | 2014-08-27 | 146 | 2 |
| K131889 | EUM 100PRO | Promedic, Inc. | 2014-04-23 | 302 | 0 |
| K130002 | SURECALL LABOR MONITOR | Reproductive Research Technologies, LP | 2013-06-28 | 177 | 0 |
| K112390 | MONICA AN24 | Monica Healthcare, Ltd. | 2012-07-13 | 330 | 0 |
| K112163 | MONICA IF24 | Monica Healthcare | 2011-08-30 | 34 | 1 |
| K101801 | MONICA AN24 | Monica Healthcare | 2011-02-03 | 220 | 0 |
| K090145 | SURECALL EMG LABOR MONITOR | Reproductive Research Technologies, LP | 2011-01-25 | 734 | 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