FDA product code DYB: Introducer, Catheter
DYB is the FDA product code for introducer, catheter. It is a Class II device, regulated under 21 CFR 870.1340 and reviewed by the Cardiovascular panel. FDA has cleared 706 510(k) submissions under DYB, 78 in the last five years, from 263 different applicants. The average 510(k) review took 110 days (median 87); 67 days on average over the last three years. FDA has posted 389 recalls for DYB devices, 71 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Introducer, Catheter |
| Device class | Class II |
| Regulation | 21 CFR 870.1340 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DYB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 24 | 104 |
| 2018 | 19 | 155 |
| 2019 | 18 | 77 |
| 2020 | 9 | 74 |
| 2021 | 12 | 101 |
| 2022 | 13 | 134 |
| 2023 | 15 | 77 |
| 2024 | 18 | 68 |
| 2025 | 16 | 66 |
| 2026 | 16 | 67 |
Compare with all 510(k) review times · Search every DYB clearance
Top DYB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| St Jude Medical | 21 | 2014-03-11 |
| Terumo Medical Corp. | 19 | 2011-10-03 |
| Cordis Corp. | 19 | 2000-07-03 |
| Merit Medical Systems, Inc. | 18 | 2025-04-25 |
| Daig Corp. | 18 | 2000-11-29 |
258 more applicants have DYB clearances. See the full list in Caduvo.
Most recent DYB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253526 | Medline Industries, LP | NAMIC Dilator and Sheath | 2026-07-29 | 258 |
| K261529 | Hartman Medical Group, LLC | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | 2026-07-06 | 59 |
| K261242 | Pendracare | SimplGuide | 2026-06-25 | 71 |
| K261950 | Health Line International Corporation | Health Line Tearaway Introducer | 2026-06-22 | 12 |
| K261492 | CenterPoint Systems, LLC | FieldFlex Steerable Sheath | 2026-06-05 | 30 |
Recalls for DYB devices
389 product recalls in 159 recall events; 71 initiated in the last five years and 66 still open. Most recent: 2026-06-15.
| Year | Recalls |
|---|---|
| 2017 | 40 |
| 2018 | 17 |
| 2019 | 12 |
| 2020 | 32 |
| 2021 | 15 |
| 2022 | 3 |
| 2023 | 18 |
| 2024 | 14 |
| 2025 | 8 |
| 2026 | 24 |
Frequently asked questions
What is FDA product code DYB?
DYB is the FDA product code for introducer, catheter. It is a Class II device, regulated under 21 CFR 870.1340 and reviewed by the Cardiovascular panel.
What device class is DYB?
Class II, regulation 21 CFR 870.1340. Typical premarket route: 510(k).
How long does a 510(k) take for product code DYB?
Across 706 cleared submissions the average was 110 days from receipt to decision (median 87).
Which companies have the most DYB clearances?
St Jude Medical (21); Terumo Medical Corp. (19); Cordis Corp. (19); Merit Medical Systems, Inc. (18); Daig Corp. (18).
Have DYB devices been recalled?
Yes: 389 product recalls across 159 recall events; the most recent began 2026-06-15.
Next steps
- Run an FDA pathway report with predicate devices for product code DYB
- Run a recall and safety report across every DYB manufacturer
- Watch product code DYB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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