FDA product code EZL: Catheter, Retention Type, Balloon
EZL is the FDA product code for catheter, retention type, balloon. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 130 510(k) submissions under EZL, 14 in the last five years, from 81 different applicants. The average 510(k) review took 166 days (median 118); 190 days on average over the last three years. FDA has posted 85 recalls for EZL devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Retention Type, Balloon |
| Device class | Class II |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EZL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 216 |
| 2018 | 9 | 168 |
| 2019 | 3 | 265 |
| 2020 | 4 | 142 |
| 2021 | 2 | 184 |
| 2022 | 2 | 80 |
| 2023 | 3 | 370 |
| 2024 | 5 | 178 |
| 2025 | 1 | 263 |
| 2026 | 3 | 129 |
Compare with all 510(k) review times · Search every EZL clearance
Top EZL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 10 | 2018-09-19 |
| Regulatory & Marketing Services, Inc. | 6 | 1996-04-10 |
| Amsino International, Inc. | 5 | 2018-09-04 |
| Teleflexmedical, Inc. | 4 | 2024-08-01 |
| Rusch Intl. | 4 | 1999-12-09 |
76 more applicants have EZL clearances. See the full list in Caduvo.
Most recent EZL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260756 | Sentinel Medical Technologies, | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | 2026-09-04 | 179 |
| K262056 | Teleflex Medical Sdn. Bhd. | Rusch Latex Gold Foley Catheter | 2026-08-05 | 48 |
| K252537 | Teleflex Medical Sdn. Bhd. | Rusch SoftSimplastic Foley Catheters | 2026-01-20 | 161 |
| K243011 | Guangdong Ecan Medical Co., Ltd. | Silicone Urethral Catheter (Silicone Urethral Catheter) | 2025-06-16 | 263 |
| K241424 | Innocare Urologics, LLC | InnoCare Specialty Foley Catheter | 2024-09-18 | 121 |
Recalls for EZL devices
85 product recalls in 14 recall events; 7 initiated in the last five years and 11 still open. Most recent: 2026-06-25.
| Year | Recalls |
|---|---|
| 2018 | 32 |
| 2019 | 4 |
| 2020 | 11 |
| 2021 | 4 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code EZL?
EZL is the FDA product code for catheter, retention type, balloon. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is EZL?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code EZL?
Across 130 cleared submissions the average was 166 days from receipt to decision (median 118).
Which companies have the most EZL clearances?
C.R. Bard, Inc. (10); Regulatory & Marketing Services, Inc. (6); Amsino International, Inc. (5); Teleflexmedical, Inc. (4); Rusch Intl. (4).
Have EZL devices been recalled?
Yes: 85 product recalls across 14 recall events; the most recent began 2026-06-25.
Next steps
- Run an FDA pathway report with predicate devices for product code EZL
- Run a recall and safety report across every EZL manufacturer
- Watch product code EZL 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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