FDA product code FOZ: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
FOZ is the FDA product code for catheter, intravascular, therapeutic, short-term less than 30 days. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel. FDA has cleared 508 510(k) submissions under FOZ, 41 in the last five years, from 225 different applicants. The average 510(k) review took 143 days (median 102); 162 days on average over the last three years. FDA has posted 394 recalls for FOZ devices, 34 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class II |
| Regulation | 21 CFR 880.5200 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FOZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 96 |
| 2018 | 1 | 217 |
| 2019 | 8 | 167 |
| 2020 | 10 | 183 |
| 2021 | 4 | 235 |
| 2022 | 8 | 240 |
| 2023 | 9 | 150 |
| 2024 | 6 | 166 |
| 2025 | 11 | 123 |
| 2026 | 7 | 197 |
Compare with all 510(k) review times · Search every FOZ clearance
Top FOZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton Dickinson Infusion Therapy Systems, Inc. | 30 | 2026-04-02 |
| Menlo Care, Inc. | 22 | 1996-04-04 |
| Parke-Davis Co. | 14 | 1986-12-04 |
| B.Braun Medical, Inc. | 12 | 2026-05-15 |
| Cook, Inc. | 11 | 2008-07-30 |
220 more applicants have FOZ clearances. See the full list in Caduvo.
Most recent FOZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260432 | Venocare, Inc. | Ruby Intravascular Catheter | 2026-09-02 | 203 |
| K260165 | Spectrum Vascular | Unimpregnated Central Venous Catheter | 2026-08-10 | 202 |
| K261041 | MedSource Labs, LLC | ClearSafe Closed System | 2026-07-10 | 101 |
| K260539 | MedSource Labs, LLC | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter | 2026-07-09 | 142 |
| K253235 | B.Braun Medical, Inc. | Introcan Safety® Deep Access XL IV Catheter | 2026-05-15 | 228 |
Recalls for FOZ devices
394 product recalls in 92 recall events; 34 initiated in the last five years and 44 still open. Most recent: 2026-03-11.
| Year | Recalls |
|---|---|
| 2017 | 98 |
| 2018 | 36 |
| 2019 | 4 |
| 2020 | 6 |
| 2021 | 13 |
| 2022 | 11 |
| 2023 | 5 |
| 2024 | 1 |
| 2025 | 11 |
| 2026 | 6 |
Frequently asked questions
What is FDA product code FOZ?
FOZ is the FDA product code for catheter, intravascular, therapeutic, short-term less than 30 days. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel.
What device class is FOZ?
Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code FOZ?
Across 508 cleared submissions the average was 143 days from receipt to decision (median 102).
Which companies have the most FOZ clearances?
Becton Dickinson Infusion Therapy Systems, Inc. (30); Menlo Care, Inc. (22); Parke-Davis Co. (14); B.Braun Medical, Inc. (12); Cook, Inc. (11).
Have FOZ devices been recalled?
Yes: 394 product recalls across 92 recall events; the most recent began 2026-03-11.
Next steps
- Run an FDA pathway report with predicate devices for product code FOZ
- Run a recall and safety report across every FOZ manufacturer
- Watch product code FOZ 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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