510(k) Report

FDA applicant

Biocardia, Inc.

San Carlos, CA6 decisions2002–20243 recalls

FDA records 6 decisions for Biocardia, Inc. (San Carlos, CA) from 2002 to 2024: 6 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 56 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Biocardia”.

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

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

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

FDA decisions per year

1in 2024

2009: 12019: 12020: 12024: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2014

2014: 3
2007high 3 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Biocardia, 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?

  • DYBIntroducer, Catheter3decisions
  • DQYCatheter, Percutaneous2decisions
  • DQOCatheter, Intravascular, Diagnostic1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 30 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 56 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 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.

  • K012749Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 20023cite it
  • K042553Biocardia Morph Universal Deflectable Guide CatheterBiocardia, Inc. · 20052cite it
  • K190941BioCardia 8.5 F Avance Steerable lntroducerBiocardia, Inc. · 20191cites it
  • K192774BioCardia 8F Morph DNA Deflectable Guide CatheterBiocardia · 20201cites it

What has FDA decided for it lately?

  • K242169Morph DNA Steerable Introducer SheathBiocardia · 2024
  • K192774BioCardia 8F Morph DNA Deflectable Guide CatheterBiocardia · 2020
  • K190941BioCardia 8.5 F Avance Steerable lntroducerBiocardia, Inc. · 2019
  • K090999Biocardia Morph Sheath GuideBiocardia, Inc. · 20093 recalls
  • K042553Biocardia Morph Universal Deflectable Guide CatheterBiocardia, Inc. · 2005
  • K012749Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002

All 4 as Biocardia, Inc. →All 2 as Biocardia →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K090999Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use…Mar 3, 2014Class II
  • K090999Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use…Mar 3, 2014Class II
  • K090999MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in…Feb 7, 2014Class II