510(k) Report

FDA product code · General hospital

Syringe, Antistick

MEGClass II21 CFR 880.5860510(k) required163 decisions since 199413 recalls

163 FDA decisions since 1994. 510(k) reviews decided 2021–2025 took a median of 206 days (half between 172 and 292). 13 recalls name this code, 1 of them Class I. The most-cited predicate is K072739, named by 11 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, general hospital panel

Twenty years of MEG 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 · MEG

1in 2025

2007: 82008: 42009: 22010: 22011: 52012: 52013: 12014: 52015: 72016: 32017: 32018: 12019: 42020: 42021: 52022: 132023: 52025: 12026 (partial year): 1
2007high 13 (2022) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEG

229in 2023

2007: 100 days median2008: 145 days median2011: 113 days median2012: 109 days median2014: 153 days median2015: 253 days median2016: 179 days median2017: 130 days median2019: 249 days median2020: 296 days median2021: 152 days median2022: 216 days median2023: 229 days median
2007high 296 (2020) · low 100 (2007)2026

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

Recalls per year · MEG

1in 2024

2008: 12010: 12013: 52015: 12024: 1, 1 Class I
2007high 5 (2013) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MEG

148in 2025

2007: 212008: 202009: 262010: 342011: 342012: 222013: 272014: 362015: 512016: 942017: 1812018: 2692019: 4972020: 3532021: 5412022: 1702023: 1202024: 1122025: 148
2007high 541 (2021) · low 20 (2008)2025

MAUDE reports naming product code MEG, 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
20078100021
20084145120
20092—026
20102—134
20115113034
20125109022
20131—527
20145153036
20157253151
20163179094
201731300181
20181—0269
201942490497
202042960353
202151520541
2022132160170
202352290120
20240—1 (1)112
20251—0148
20261—0—
FIG. 1 — MEG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MEG? 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 880.5860.