FDA product code · Anesthesiology

Tracheal Suction Set

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

OFSClass I21 CFR 868.68100 decisions0 recalls

0 FDA decisions. No recall names this code.

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 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.

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, anesthesiology panel

Twenty years of OFS 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 — OFS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OFS? 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 868.6810.

OYI Non-Bronchoscopic Bronchoalveolar Lavage…BSY Catheters, Suction, Tracheobronchial OFR Tracheobronchial Suction Catheter Kit OFO Airway Suction Kit