Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Northeast Scientific, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
542 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-867 | Northeast Scientific, Inc. | 2025-05-12 | 74 | 0 |
| K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Northeast Scientific, Inc. | 2023-02-03 | 127 | 0 |
| K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | Northeast Scientific, Inc. | 2022-07-01 | 161 | 1 |
| K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | Northeast Scientific, Inc. | 2020-06-22 | 147 | 0 |
| K090661 | NES REPROCESSED VARICOSE VEIN RF CATHETER | Northeast Scientific, Inc. | 2010-07-21 | 496 | 0 |
| K060676 | NES REPROCESSED ENDOSCOPIC TROCAR | Northeast Scientific, Inc. | 2007-09-07 | 542 | 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