Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Natec Medical , Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
347 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | 2025-12-18 | 178 | 0 |
| K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | 2024-12-18 | 246 | 0 |
| K220410 | Ebony HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | 2022-06-29 | 135 | 0 |
| K210012 | Tamarin Blue PTCA RX Dilatation Catheter | Natec Medical , Ltd. | 2021-07-09 | 186 | 0 |
| K141933 | FILAO NC RX PTCA DILATATION CATHETER | Natec Medical , Ltd. | 2015-06-28 | 347 | 0 |
| K143041 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 | Natec Medical , Ltd. | 2015-06-04 | 225 | 0 |
| K143036 | Ebony PTA 0.035 Peripheral Dilatation Catheter | Natec Medical , Ltd. | 2015-03-30 | 159 | 0 |
| K142459 | Ebony PTA 0.014 RX Peripheral Dilatation Catheter | Natec Medical , Ltd. | 2015-02-03 | 154 | 0 |
| K112735 | TAMARIN BLUE PTCA RX DILATATION CATHETER | Natec Medical , Ltd. | 2012-11-02 | 409 | 0 |
| K112513 | EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER | Natec Medical , Ltd. | 2011-12-09 | 101 | 0 |
| K103354 | EBONY PTA .035 PERIPHERAL DILATATION CATHETER | Natec Medical , Ltd. | 2011-02-23 | 99 | 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