510(k) Report

FDA product code · Gastroenterology and urology

Pump, Air, Non-Manual, For Endoscope

FEQClass II21 CFR 876.1500510(k) required21 decisions since 20005 recalls

21 FDA decisions since 2000. 510(k) reviews decided 2021–2025 took a median of 28 days (half between 28 and 28). 5 recalls name this code, 0 of them Class I. The most-cited predicate is K092429, named by 13 later devices.

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, gastroenterology and urology panel

Twenty years of FEQ 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.

FDA decisions per year · FEQ

1in 2022

2009: 12010: 32011: 12012: 32013: 12014: 12015: 22016: 32017: 12018: 22019: 12022: 1
2007high 3 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FEQ

29in 2016

2010: 84 days median2012: 141 days median2016: 29 days median
2007high 141 (2012) · low 29 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FEQ

1in 2024

2011: 12013: 12015: 12024: 12026 (partial year): 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FEQ

341in 2025

2008: 12009: 12011: 12012: 22013: 42015: 12016: 12017: 42018: 222019: 62020: 52021: 32022: 192023: 112024: 7052025: 341
2007high 705 (2024) · low 0 (2007)2025

MAUDE reports naming product code FEQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20091—01
201038400
20111—11
2012314102
20131—14
20141—00
20152—11
201632901
20171—04
20182—022
20191—06
20200—05
20210—03
20221—019
20230—011
20240—1705
20250—0341
20260—1—
FIG. 1 — FEQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FEQ? 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 876.1500.