510(k) Report

FDA product code · General hospital

Needle, Interosseous

MHCClass II21 CFR 880.5570510(k) required2 decisions since 20210 recalls

2 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 78 days (half between 53 and 102). No recall names this code. The most-cited predicate is K203193, named by 1 later device.

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 MHC 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 · MHC

1in 2022

2021: 12022: 1
2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHC

Too few MHC 510(k)s in any year since 2007 to give a median.

Recalls per year · MHC

No recall names MHC since 2007.

Adverse event reports per year · MHC

7in 2023

2007: 42020: 12023: 7
2007high 7 (2023) · low 0 (2008)2025

MAUDE reports naming product code MHC, 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—04
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20211—00
20221—00
20230—07
20240—00
20250—00
20260—0—
FIG. 1 — MHC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MHC? 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 880.5570.