Arrow International, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Arrow International, Inc.” (first 2003, latest 2025), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 80 days. Since 2017 the median was 85 days, against 139 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Teleflex, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 108 |
| 2013 | 2 | 66 |
| 2014 | 1 | 74 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 175 |
| 2018 | 0 | — |
| 2019 | 2 | 148 |
| 2020 | 2 | 30 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 110 |
| 2024 | 0 | — |
| 2025 | 1 | 30 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Arrow International, Inc. 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 139 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | 7 | 7 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 5 | 5 |
| CAZ | Anesthesia Conduction Kit | 4 | 4 |
| MSD | Catheter, Hemodialysis, Implanted | 4 | 4 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
Review panels
Most recent Arrow International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250542 | AC3 Range Intra-Aortic Balloon Pump | DSP | 2025-03-26 | 30 |
| K232343 | AC3 Series IABP | DSP | 2023-08-30 | 26 |
| K222341 | Arrow 0.2 Micron Flat Filter, GVS | CAZ | 2023-02-13 | 194 |
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | DSP | 2020-05-27 | 30 |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit | DSP | 2020-04-09 | 30 |
| K190101 | UltraFlex IAB | DSP | 2019-06-28 | 157 |
| K190117 | Fiberoptix IAB | DSP | 2019-06-13 | 140 |
| K162820 | AC3 Series IABP System | DSP | 2017-03-31 | 175 |
| K141051 | VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU | MSD | 2014-07-07 | 74 |
| K130192 | NEXTSTEP RETROGRADE | MSD | 2013-05-10 | 105 |
12 earlier clearances. See the full list in Caduvo.
Recalls
708 product recalls in 132 recall events; 94 initiated in the last five years. Most recent: 2026-04-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Arrow Intl., Inc. (110 510(k)s)
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (8 510(k)s)
- Arrow International (Subsidiary of Teleflex Inc.) (6 510(k)s)
- Arrow International, LLC (A subsidiary of Teleflex, Inc.) (4 510(k)s)
- Arrow International, Inc. (Subsidiary of Teleflex (2 510(k)s)
- Arrow X-Ray Corp. (2 510(k)s)
- Arrow Industries, LLC (1 510(k)s)
- Arrow Int'L. (1 510(k)s)
- Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) (1 510(k)s)
- Arrow International (A Subsidiary of Teleflex, Inc.) (1 510(k)s)
- Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) (1 510(k)s)
- Arrow International, Inc (Subsidiary of Teleflex I (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Arrow International, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Arrow International, Inc.” (first 2003, latest 2025), across 6 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Arrow International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arrow International, Inc. is 80 days. Since 2017: 85 days, versus 139 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Arrow International, Inc.?
The most frequent FDA product codes under this applicant name are DSP (System, Balloon, Intra-Aortic And Control, 7); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 5); CAZ (Anesthesia Conduction Kit, 4).
Next steps
- See all 22 Arrow International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSP, Arrow International, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.