510(k) Report

FDA applicant

Bioaccess, Inc.

Silver Spring, MD3 decisions1995–19970 recalls

FDA records 3 decisions for Bioaccess, Inc. (Silver Spring, MD) from 1995 to 1997: 3 510(k) clearances. Most are in product codes GDM (Needle, Aspiration And Injection, Reusable) and KNW (Instrument, Biopsy). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Bioaccess, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • GDMNeedle, Aspiration And Injection, Reusable2decisions
  • KNWInstrument, Biopsy1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K953064Bioaccess Marrow Harvest SystemBioaccess, Inc. · 19952cite it

What has FDA decided for it lately?

  • K971114Bioaccess Marrow Harvest SystemBioaccess, Inc. · 1997
  • K954151Bioaccess Bone Biopsy SystemBioaccess, Inc. · 1995
  • K953064Bioaccess Marrow Harvest SystemBioaccess, Inc. · 1995

All 3 as Bioaccess, Inc. →