510(k) Report

FDA product code · Clinical toxicology

Fluorometer, Lead (Dedicated Instruments)

DOXClass II21 CFR 862.3550510(k) required4 decisions since 19830 recalls

4 FDA decisions since 1983. No recall names this code. The most-cited predicate is K832030, 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, clinical toxicology panel

Twenty years of DOX 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 · DOX

FDA has decided no DOX device since 2007.

Median 510(k) review, days · DOX

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

Recalls per year · DOX

No recall names DOX since 2007.

Adverse event reports per year · DOX

2in 2014

2014: 2
2007high 2 (2014) · low 0 (2007)2025

MAUDE reports naming product code DOX, 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—00
20120—00
20130—00
20140—02
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 — DOX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DOX? 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

Which predicates do DOX devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K832030Heparin Coated Stainless Steel/TeflonArgon Medical Corp. · 19831cites it

Which DOX devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K014195Kayak Hydrophilic Guide WiresBoston Scientific Corp · 20022generations

What has FDA decided in DOX lately?

  • K014195Kayak Hydrophilic Guide WiresBoston Scientific Corp · 2002
  • K944226Msi Procedure KitMsi, Inc. · 1995
  • K900822Hydro-Sil (TM) Coated GuidewiresNational-Standard Medical Products · 1990
  • K832030Heparin Coated Stainless Steel/TeflonArgon Medical Corp. · 1983

All 4 DOX decisions →

Related product codes

Other codes under 21 CFR 862.3550.

DMK Lead, Protoporphyrin, FluorometricDIJ Lead, Delta Amino Levulinic AcidDOF Lead, Atomic AbsorptionDNX Lead, Protoporphyrin Zinc Method, Fluorometric