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Scoping review

FDA product code · Gastroenterology, Urology · Class 2

FDF: Colonoscope And Accessories, Flexible/Rigid

FDF is FDA's product code for "Colonoscope And Accessories, Flexible/Rigid": a Class 2 device classified under 21 CFR 876.1500, reviewed by the Gastroenterology, Urology panel.

510(k) review time for FDF

Across 40 510(k) clearances under FDF decided from 2018-01-01 to 2026-10-06, the median was 158 days from FDA receipt to decision. Half took between 56 and 223 days, and 80% were decided within 237 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, FDF, decisions 2018-01-01 to 2026-10-06 (n = 40)
Fastest20
25th percentile56
Median158
75th percentile223
80th percentile237
90th percentile268
Slowest448
Median days by decision year, FDF (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20181017
20221475
20232036
2026 (to 10-06, partial)1475

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.

FDF in the public FDA record

Records naming FDF, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years115
Device recalls25
Establishment listings228
GUDID device identifiers736

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

14 FDA recognized consensus standards cite FDF, 2 of them recognized only in part, among them IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11; ISO 8600-1 Fourth Edition 2015-10-15. 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
  • 6-521 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
  • 9-110 ISO 8600-1 Fourth Edition 2015-10-15 — Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
  • 9-123 ISO 8600-3 Second edition 2019-08 (partial recognition) — Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics.
  • 9-124 CIE ISO 11664-1:2019 — Colorimetry - Part 1: CIE standard colorimetric observers
  • 9-126 ISO CIE 11664-3 First edition 2019-06 — Colorimetry - Part 3: CIE tristimulus values
  • 9-127 ISO CIE 11664-4 First edition 2019-06 — Colorimetry - Part 4: CIE 1976 L*a*b* colour space
  • 9-129 ISO CIE 61966-2-1 First edition 1999-10 — Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)]
  • 9-130 ISO 8600-6 Second edition 2020-09 — Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
  • 9-131 ISO 8600-5 Second Edition 2020-10 — Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
  • 9-139 CIE ISO 11664-5:2016 — Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u'v' uniform chromaticity scale diagram
  • 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.

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