510(k) Report

FDA product code · Gastroenterology and urology

Tube, Feeding

FPDClass II21 CFR 876.5980510(k) required59 decisions since 19766 recalls

59 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 51 days (half between 51 and 51). 6 recalls name this code, 0 of them Class I. The most-cited predicate is K060944, named by 7 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 FPD 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 · FPD

1in 2024

2007: 12008: 42009: 42010: 42011: 22012: 12013: 22019: 12024: 1
2007high 4 (2008) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPD

118in 2010

2008: 76 days median2009: 69 days median2010: 118 days median
2007high 118 (2010) · low 69 (2009)2026

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

Recalls per year · FPD

1in 2019

2015: 12018: 32019: 1
2007high 3 (2018) · low 0 (2007)2026

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

Adverse event reports per year · FPD

10in 2025

2007: 192008: 242009: 402010: 212011: 152012: 322013: 382014: 642015: 552016: 1022017: 342018: 302019: 192020: 312021: 242022: 192023: 552024: 412025: 10
2007high 102 (2016) · low 10 (2025)2025

MAUDE reports naming product code FPD, 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
20071—019
2008476024
2009469040
20104118021
20112—015
20121—032
20132—038
20140—064
20150—155
20160—0102
20170—034
20180—330
20191—119
20200—031
20210—024
20220—019
20230—055
20241—041
20250—010
20260—0—
FIG. 1 — FPD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FPD? 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 876.5980.