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FDA product code · Gastroenterology, Urology · Class 2

QNP: Gastrointesinal Lesion Software Detection System

QNP is FDA's product code for "Gastrointesinal Lesion Software Detection System": a Class 2 device classified under 21 CFR 876.1520, reviewed by the Gastroenterology, Urology panel.

510(k) review time for QNP

Across 22 510(k) clearances under QNP decided from 2018-01-01 to 2026-10-06, the median was 32 days from FDA receipt to decision. Half took between 28 and 203 days, and 80% were decided within 232 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, QNP, decisions 2018-01-01 to 2026-10-06 (n = 22)
Fastest27
25th percentile28
Median32
75th percentile203
80th percentile232
90th percentile262
Slowest331
Median days by decision year, QNP (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
2024295
2025285
2026 (to 10-06, partial)1695

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.

FDA-recognized standards that cite QNP

2 FDA recognized consensus standards cite QNP, among them ISO CIE 11664-2 First edition 2022-08; ISO CIE 11664-6 Second edition 2022-08. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 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.

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