510(k) Report

FDA applicant

Mark Abramson, D.D.S., Inc.

Redwood City, CA2 decisions2003–20190 recalls

FDA records 2 decisions for Mark Abramson, D.D.S., Inc. (Redwood City, CA) from 2003 to 2019: 2 510(k) clearances. Most are in product codes LRK (Device, Anti-Snoring) and PLC (Sleep Appliances With Patient Monitoring). Its devices cite 5 predicates, 0 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, dental panel, where it files most

How often FDA has decided Mark Abramson, D.D.S., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mark Abramson, D.D.S., 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?

  • LRKDevice, Anti-Snoring1decision
  • PLCSleep Appliances With Patient Monitoring1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K030440Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 20036cite it

What has FDA decided for it lately?

  • K181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorMark Abramson, D.D.S., Inc. · 2019
  • K030440Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003

All 2 as Mark Abramson, D.D.S., Inc. →

Other applicant names beginning “Mark”

FDA records each applicant name separately; these may or may not be the same firm.

Mark One Healthcare Products 5Mark H. Friedman 2Mark-Clark 2Mark Solutions, Inc. 1Mark Sullivan, M.D., P.C. 1