510(k) Report

FDA product code · General hospital

Saline, Vascular Access Flush

NGTClass II21 CFR 880.5200510(k) required41 decisions since 200124 recalls

41 FDA decisions since 2001. 510(k) reviews decided 2021–2025 took a median of 145 days (half between 123 and 178). 24 recalls name this code, 6 of them Class I. The most-cited predicate is K082837, named by 3 later devices.

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

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, general hospital panel

Twenty years of NGT 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 · NGT

1in 2025

2008: 12009: 12010: 22011: 32012: 42013: 12014: 32015: 12016: 12017: 22018: 12019: 22020: 22022: 32023: 62024: 12025: 1
2007high 6 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NGT

142in 2023

2011: 219 days median2012: 106 days median2014: 87 days median2022: 151 days median2023: 142 days median
2007high 219 (2011) · low 87 (2014)2026

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

Recalls per year · NGT

1in 2025

2007: 22009: 12010: 72011: 12012: 12013: 1, 1 Class I2016: 1, 1 Class I2019: 22021: 1, 1 Class I2022: 12023: 3, 2 Class I2025: 12026 (partial year): 1, 1 Class I
2007high 7 (2010) · low 0 (2008)2026

Class I (6 since 2007) Class II/III not classified

Adverse event reports per year · NGT

212in 2025

2007: 312008: 642009: 182010: 232011: 202012: 52013: 252014: 252015: 142016: 822017: 562018: 2702019: 3402020: 3222021: 5662022: 2822023: 3132024: 3322025: 212
2007high 566 (2021) · low 5 (2012)2025

MAUDE reports naming product code NGT, 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—231
20081—064
20091—118
20102—723
20113219120
2012410615
20131—1 (1)25
2014387025
20151—014
20161—1 (1)82
20172—056
20181—0270
20192—2340
20202—0322
20210—1 (1)566
202231511282
202361423 (2)313
20241—0332
20251—1212
20260—1 (1)—
FIG. 1 — NGT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NGT? 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 880.5200.