Balt USA, LLC: FDA clearances and approvals
Balt USA, LLC has 19 FDA 510(k) clearances (first 2018, latest 2026), plus 1 PMA decision, across 9 product codes in 2 review panels. Median 510(k) review time: 143 days. Since 2017 its median was 143 days, against 114 days for all cleared 510(k)s in the same product codes. openFDA lists 8 product recalls by a recalling firm named Balt USA, LLC. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 37 |
| 2019 | 2 | 166 |
| 2020 | 1 | 25 |
| 2021 | 1 | 163 |
| 2022 | 2 | 150 |
| 2023 | 1 | 191 |
| 2024 | 4 | 168 |
| 2025 | 4 | 50 |
| 2026 | 3 | 108 |
Review time against the same product codes
Since 2017, Balt USA, LLC's cleared 510(k)s took a median 143 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | 6 | 6 |
| HCG | Device, Neurovascular Embolization | 5 | 5 |
| KRA | Catheter, Continuous Flush | 2 | 2 |
| NRY | Catheter, Thrombus Retriever | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 1 | 1 |
| MJN | Catheter, Intravascular Occluding, Temporary | 1 | 1 |
| MOF | Guide, Wire, Catheter, Neurovasculature | 1 | 1 |
| SGU | Neurovascular Liquid Embolic Agent | 1 | 0 |
Review panels
- Neurology (15)
- Cardiovascular (5)
Most recent Balt USA, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260199 | SLIM Microcatheter | QJP | 2026-07-13 | 172 |
| K254223 | Next Generation 088 Catheter | QJP | 2026-04-16 | 108 |
| K254221 | Optima Coil System (OptiOne Coil System) | HCG | 2026-01-27 | 29 |
| K252569 | Carrier XL Delivery Catheter | QJP | 2025-10-22 | 69 |
| K252700 | Optima Coil System (Optima Packing Coil System) | HCG | 2025-09-26 | 30 |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | NRY | 2025-06-03 | 162 |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | KRD | 2025-05-30 | 28 |
| K242376 | Next Generation Access Platform | QJP | 2024-12-30 | 143 |
| K242582 | Optima Coil System (OptiBlock Line Extension) | HCG | 2024-09-27 | 28 |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | NRY | 2024-07-02 | 193 |
9 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250009 | PMA | SQUID Liquid Embolic Agent (LEA) | 2026-01-30 |
Recalls
8 product recalls in 6 recall events; 8 initiated in the last five years. Most recent: 2025-09-25.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Balt USA, LLC is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04410146: The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM) (Completed, started 2020-11-01)
Frequently asked questions
How many FDA 510(k) clearances does Balt USA, LLC have?
Balt USA, LLC has 19 FDA 510(k) clearances (first 2018, latest 2026), plus 1 PMA decision, across 9 product codes in 2 review panels.
How long does FDA take to clear Balt USA, LLC's 510(k)s?
The median time from FDA receipt to decision across Balt USA, LLC's cleared 510(k)s is 143 days. Since 2017: 143 days, versus 114 days for all cleared 510(k)s in the same product codes.
What devices does Balt USA, LLC make?
Its most frequent FDA product codes are QJP (Catheter, Percutaneous, Neurovasculature, 6); HCG (Device, Neurovascular Embolization, 5); KRA (Catheter, Continuous Flush, 2).
Has Balt USA, LLC had device recalls?
openFDA lists 8 product recalls in 6 recall events by a recalling firm whose name matches Balt USA, LLC; the most recent began 2025-09-25. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 19 Balt USA, LLC clearances with predicates and recalls
- Run predicate analysis for product code QJP, Balt USA, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.