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Scoping review

FDA product code · General, Plastic Surgery · Class 2

NEY: System, Ablation, Microwave And Accessories

NEY is FDA's product code for "System, Ablation, Microwave And Accessories": a Class 2 device classified under 21 CFR 878.4400, reviewed by the General, Plastic Surgery panel.

510(k) review time for NEY

Across 36 510(k) clearances under NEY decided from 2018-01-01 to 2026-10-06, the median was 152 days from FDA receipt to decision. Half took between 96 and 255 days, and 80% were decided within 269 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, NEY, decisions 2018-01-01 to 2026-10-06 (n = 36)
Fastest30
25th percentile96
Median152
75th percentile255
80th percentile269
90th percentile326
Slowest448
Median days by decision year, NEY (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20201787
20231559
2024947

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.

NEY in the public FDA record

Records naming NEY, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years68
Device recalls27
Establishment listings96

Counts of records, not of devices or events. Adverse event reports for NEY 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 NEY

3 FDA recognized consensus standards cite NEY, 1 of them recognized only in part, among them IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-6 Edition 2.1 2016-04; IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 6-389 IEC 60601-2-2 Edition 6.0 2017-03 (partial recognition) — Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
  • 6-423 IEC 60601-2-6 Edition 2.1 2016-04 — CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
  • 6-521 IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11 — Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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