PRNClass I

Pediatric Position Holder

21 CFR 880.5680 / General Hospital

PRN is the FDA product code for Pediatric Position Holder, a class I device type, regulated under 21 CFR 880.5680. FDA's definition for this code reads: "Device used to physically restrain a pediatric patient for a short surgical or clinical procedure such as circumcision. Not intended for prolonged positioning". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PRN
Device name: Pediatric Position Holder
FDA definition: Device used to physically restrain a pediatric patient for a short surgical or clinical procedure such as circumcision. Not intended for prolonged positioning.
Regulation: 21 CFR 880.5680
Device class: Class I
Review panel: General Hospital
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PRN

FDA records hold no clearances under product code PRN.

Recent recalls

Product code PRN

FDA records show no recalls under product code PRN.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)