510(k) Report

FDA applicant

Innovacon, Inc.

San Diego, CA3 decisions2006–200711 recalls

FDA records 3 decisions for Innovacon, Inc. (San Diego, CA) from 2006 to 2007: 3 510(k) clearances. Most are in product codes DKZ (Enzyme Immunoassay, Amphetamine) and KHE (Reagent, Occult Blood). Its devices cite 7 predicates, 0 of them its own earlier devices. 11 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided Innovacon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2007: 12009: 52011: 12013: 12022: 22026 (partial year): 1
2007high 5 (2009) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Innovacon, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Innovacon, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DKZEnzyme Immunoassay, Amphetamine1decision
  • KHEReagent, Occult Blood1decision
  • JHIVisual, Pregnancy Hcg, Prescription Use1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K061718Innovacon Spectrum II Test CardInnovacon, Inc. · 20067cite it

What has FDA decided for it lately?

  • K063673Innovacon Flipcard Fecal Occult Blood Test DeviceInnovacon, Inc. · 2007
  • K061718Innovacon Spectrum II Test CardInnovacon, Inc. · 20066 recalls
  • K062361Innovacon HCG Uktra Test DeviceInnovacon, Inc. · 20065 recalls

All 3 as Innovacon, Inc. →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K062361McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20…Aug 20, 2026Class II
  • K062361a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy…May 25, 2022Class II
  • K062361a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum /…May 25, 2022Class II
  • K062361Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo…Apr 16, 2013Class II
  • K061718Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the…Jun 10, 2011
  • K061718Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product…Apr 27, 2009