Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Balt USA, LLC · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
143 daysmedian FDA review time
193 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260199 | SLIM Microcatheter | Balt USA, LLC | 2026-07-13 | 172 | 0 |
| K254223 | Next Generation 088 Catheter | Balt USA, LLC | 2026-04-16 | 108 | 0 |
| K254221 | Optima Coil System (OptiOne Coil System) | Balt USA, LLC | 2026-01-27 | 29 | 0 |
| K252569 | Carrier XL Delivery Catheter | Balt USA, LLC | 2025-10-22 | 69 | 0 |
| K252700 | Optima Coil System (Optima Packing Coil System) | Balt USA, LLC | 2025-09-26 | 30 | 0 |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | 2025-06-03 | 162 | 0 |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | Balt USA, LLC | 2025-05-30 | 28 | 0 |
| K242376 | Next Generation Access Platform | Balt USA, LLC | 2024-12-30 | 143 | 1 |
| K242582 | Optima Coil System (OptiBlock Line Extension) | Balt USA, LLC | 2024-09-27 | 28 | 0 |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing | Balt USA, LLC | 2024-07-02 | 193 | 0 |
| K234074 | Next Generation Access Catheter | Balt USA, LLC | 2024-07-02 | 193 | 0 |
| K230609 | NG Delivery Catheter | Balt USA, LLC | 2023-09-13 | 191 | 0 |
| K223386 | Optima Coil System | Balt USA, LLC | 2022-12-06 | 29 | 1 |
| K213435 | MAGIC Flow-Dependent Microcatheter | Balt USA, LLC | 2022-07-19 | 270 | 0 |
| K202366 | MAGIC Infusion Catheter | Balt USA, LLC | 2021-01-29 | 163 | 0 |
| K200030 | Optima Coil System | Balt USA, LLC | 2020-02-01 | 25 | 3 |
| K183045 | Eclipse 2L | Balt USA, LLC | 2019-04-30 | 179 | 0 |
| K182918 | Ballast 088 Long Sheath | Balt USA, LLC | 2019-03-21 | 153 | 0 |
| K182337 | HYBRID Guidewire | Balt USA, LLC | 2018-10-04 | 37 | 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