510(k) Report

FDA product code · Anesthesiology

Needle, Spinal, Short Term

MIAClass II21 CFR 868.5150510(k) required10 decisions since 19930 recalls

10 FDA decisions since 1993. No recall names this code. The most-cited predicate is K942442, named by 3 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, anesthesiology panel

Twenty years of MIA 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 · MIA

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MIA

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

Recalls per year · MIA

No recall names MIA since 2007.

Adverse event reports per year · MIA

14in 2025

2007: 52008: 62009: 42010: 12012: 32013: 22014: 42015: 122016: 232017: 152018: 142019: 92020: 52021: 42022: 192023: 122024: 232025: 14
2007high 23 (2016) · low 0 (2011)2025

MAUDE reports naming product code MIA, 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—05
20080—06
20090—04
20100—01
20110—00
20120—03
20130—02
20140—04
20150—012
20160—023
20170—015
20181—014
20190—09
20200—05
20210—04
20220—019
20230—012
20240—023
20250—014
20260—0—
FIG. 1 — MIA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MIA? 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 868.5150.