Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PBQ · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
128 daysmedian FDA review time
207 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260380 | Mendit | Escala Medical, Ltd. | 2026-03-04 | 27 | 0 |
| K230730 | Apyx | Escala Medical | 2023-07-25 | 131 | 0 |
| K220420 | Saffron Fixation System | Coloplast A/S | 2022-06-10 | 116 | 0 |
| K213783 | Apyx | Escala Medical | 2022-04-05 | 123 | 0 |
| K160569 | NeuGuide | Pop Medical Solutions | 2016-07-06 | 128 | 0 |
| K130059 | ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP | Ibi Israel Biomedical Innovations , Ltd. | 2013-07-29 | 200 | 0 |
| K120831 | ANCHORSURE | Neomedic International S.L. | 2012-10-12 | 207 | 0 |
| K042603 | GYNECARE PROLENE FASTENER SYSTEM | ETHICON, Inc. | 2004-12-22 | 89 | 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