510(k) Report

FDA product code · Hematology

Tissue Culture, Accessories, Dental

NVGClass I21 CFR 864.2240510(k) exempt0 decisions0 recalls

FDA lists NVG as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

Intended to temporarilty nourish cells on an avulsed tooth

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, hematology panel

Twenty years of NVG 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 · NVG

FDA has decided no NVG device since 2007.

Median 510(k) review, days · NVG

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

Recalls per year · NVG

No recall names NVG since 2007.

Adverse event reports per year · NVG

No MAUDE report names NVG since 2007.

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—00
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 — NVG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NVG? 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 864.2240.