510(k) Report

FDA applicant

Aardvark Medical, Inc.

Ross, CA2 decisions2008–20230 recalls

FDA records 2 decisions for Aardvark Medical, Inc. (Ross, CA) from 2008 to 2023: 2 510(k) clearances. Most are in product codes QBD (Microbial Nucleic Acid Storage And…) and JCX (Apparatus, Suction, Ward Use, Portable…). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Aardvark Medical”.

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

FIG. A — Illustration, microbiology panel, where it files most

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

FDA decisions per year

1in 2023

2008: 12023: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Aardvark Medical, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aardvark Medical, 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?

  • QBDMicrobial Nucleic Acid Storage And Stabilization Device1decision
  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K082762Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 20082cite it

What has FDA decided for it lately?

  • K221664CLEARinse CTS Specimen Collection and Transport SystemAardvark Medical, Inc. · 2023
  • K082762Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008

The one decision as Aardvark Medical, Inc. →The one decision as Aardvark Medical →