Health Line International Corporation: FDA clearances and approvals
Health Line International Corporation has 12 FDA 510(k) clearances (first 2006, latest 2026), across 8 product codes in 3 review panels. Median 510(k) review time: 103 days. Since 2017 its median was 85 days, against 115 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 71 |
| 2013 | 1 | 60 |
| 2014 | 2 | 243 |
| 2015 | 0 | — |
| 2016 | 1 | 145 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 85 |
| 2020 | 2 | 172 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 176 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 12 |
Review time against the same product codes
Since 2017, Health Line International Corporation's cleared 510(k)s took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 | 3 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 1 | 1 |
| MSD | Catheter, Hemodialysis, Implanted | 1 | 1 |
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | 1 | 1 |
Review panels
Most recent Health Line International Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261950 | Health Line Tearaway Introducer | DYB | 2026-06-22 | 12 |
| K222170 | Power Acute Triple Lumen Hemodialysis Catheter | NIE | 2023-01-13 | 176 |
| K200426 | Acute Dual Lumen Hemodialysis Catheter | MPB | 2020-12-24 | 307 |
| K200263 | Health Line CT Midline Catheter | FOZ | 2020-03-12 | 38 |
| K192533 | Health Line CT CVC | FOZ | 2019-12-10 | 85 |
| K160448 | ARTLINE | DQY | 2016-07-12 | 145 |
| K140270 | NEXUS MIDLINE CT CATHETER | FOZ | 2014-08-20 | 198 |
| K130851 | CASCADE HEMODIALYSIS/APHERESIS CATHETER | MSD | 2014-01-09 | 288 |
| K130034 | UNI-PICC | LJS | 2013-03-08 | 60 |
| K120548 | HLIC NEEDLE-LESS VALVE | FPA | 2012-05-04 | 71 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Health Line International Corporation.
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.
Frequently asked questions
How many FDA 510(k) clearances does Health Line International Corporation have?
Health Line International Corporation has 12 FDA 510(k) clearances (first 2006, latest 2026), across 8 product codes in 3 review panels.
How long does FDA take to clear Health Line International Corporation's 510(k)s?
The median time from FDA receipt to decision across Health Line International Corporation's cleared 510(k)s is 103 days. Since 2017: 85 days, versus 115 days for all cleared 510(k)s in the same product codes.
What devices does Health Line International Corporation make?
Its most frequent FDA product codes are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 3); FPA (Set, Administration, Intravascular, 2); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 2).
Has Health Line International Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Health Line International Corporation. Related entities may recall under other names.
Next steps
- See all 12 Health Line International Corporation clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Health Line International Corporation'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.