FDA product code PPB: Foley Catheter Kit (Excludes Hiv Testing)
PPB is the FDA product code for foley catheter kit (excludes hiv testing). It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. Devices under PPB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 14 recalls for PPB devices, 14 initiated in the last five years.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Foley Catheter Kit (Excludes Hiv Testing) |
| Device class | Class II |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for PPB devices
14 product recalls in 14 recall events; 14 initiated in the last five years and 14 still open. Most recent: 2026-03-19.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 5 |
| 2025 | 2 |
| 2026 | 3 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
Frequently asked questions
What is FDA product code PPB?
PPB is the FDA product code for foley catheter kit (excludes hiv testing). It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is PPB?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k) exempt.
Have PPB devices been recalled?
Yes: 14 product recalls across 14 recall events; the most recent began 2026-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code PPB
- Run a recall and safety report across every PPB manufacturer
- Watch product code PPB 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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