FDA product code · Ear, nose and throat

Block, Cutting, Ent, Non-Sterile

Name: FDA decisions, review times, recalls and adverse event reports for product code NNR
Creator: 510(k) Report

NNRClass I21 CFR 874.3540510(k) exempt0 decisions0 recalls

FDA lists NNR as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 874.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

Prosthesis modification instrument for ossicular replacement surgery; see product code JXS.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ear, nose and throat panel

Twenty years of NNR at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — NNR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NNR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 874.3540.

JYB Vise, Ossicular Finger, Sterile JXY Jig, Piston Cutting, Ent, Sterile NNS Instrument, Prosthesis Modification For…JXT Crimper, Wire, Ent, Sterile NNO Jig, Piston Cutting, Ent, Non-Sterile JXW Die, Wire Bending, Ent, Sterile NNN Crimper, Wire, Ent, Non-Sterile NNT Punch, Gelfoam, Non-Sterile JYA Scissors, Wire Cutting, Ent, Sterile JXS Block, Cutting, Ent, Sterile NNV Vise, Ossicular Finger, Non-Sterile NNP Die, Wire Bending, Ent, Non-Sterile