FDA product code · Ear, Nose, Throat · Class 2
EOX: Esophagoscope (Flexible Or Rigid)
EOX is FDA's product code for "Esophagoscope (Flexible Or Rigid)": a Class 2 device classified under 21 CFR 874.4710, reviewed by the Ear, Nose, Throat panel.
510(k) review time for EOX
Across 11 510(k) clearances under EOX decided from 2018-01-01 to 2026-10-06, the median was 121 days from FDA receipt to decision. Half took between 73 and 173 days, and 80% were decided within 183 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 73 |
| Median | 121 |
| 75th percentile | 173 |
| 80th percentile | 183 |
| 90th percentile | 210 |
| Slowest | 308 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
EOX in the public FDA record
| Device recalls | 8 |
|---|---|
| GUDID device identifiers | 442 |
Counts of records, not of devices or events. Adverse event reports for EOX are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite EOX
5 FDA recognized consensus standards cite EOX, among them IEC 60601-2-18: Edition 3.0 2009-08; ISO 8600-6 Second edition 2020-09; ISO 8600-4 Third Edition 2023-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 9-114 IEC 60601-2-18: Edition 3.0 2009-08 — Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- 9-130 ISO 8600-6 Second edition 2020-09 — Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
- 9-146 ISO 8600-4 Third Edition 2023-01 — Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
- 9-147 ISO CIE 11664-2 First edition 2022-08 — Colorimetry - Part 2: CIE standard illuminants
- 9-148 ISO CIE 11664-6 Second edition 2022-08 — Colorimetry - Part 6: CIEDE2000 colour-difference formula
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.