# Dialysis Administration Kit
> **Product code: PEV** · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5820
## Classification
- **FDA Product Code:** PEV
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 876.5820
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 7
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 28
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PEV)
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