510(k) Report

FDA product code · Clinical toxicology

Bacillus Subtilis Microbiology Assay, Tobramycin

DIDClass II21 CFR 862.3900510(k) required5 decisions since 19780 recalls

5 FDA decisions since 1978. No recall names this code.

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, clinical toxicology panel

Twenty years of DID 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 · DID

FDA has decided no DID device since 2007.

Median 510(k) review, days · DID

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

Recalls per year · DID

No recall names DID since 2007.

Adverse event reports per year · DID

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code DID, 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—00
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — DID by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DID? 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 862.3900.