510(k) Report

FDA applicant

Nova Health Systems, Inc.

Blackwood, NJ3 decisions1978–19900 recalls

FDA records 3 decisions for Nova Health Systems, Inc. (Blackwood, NJ) from 1978 to 1990: 3 510(k) clearances. Most are in product codes BYL (Tent, Oxygen) and FNM (Mattress, Air Flotation, Alternating Pressure). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Nova Health Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • BYLTent, Oxygen1decision
  • FNMMattress, Air Flotation, Alternating Pressure1decision
  • IQKOrthosis, Cervical1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K893713Nova Oxygen TentNova Health Systems, Inc. · 19891cites it

What has FDA decided for it lately?

  • K895477Nova PillowNova Health Systems, Inc. · 1990
  • K893713Nova Oxygen TentNova Health Systems, Inc. · 1989
  • K780502Nova Air Floatation SystemNova Health Systems, Inc. · 1978

All 3 as Nova Health Systems, Inc. →

Other applicant names beginning “Nova”

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

Nova Biomedical Corp. 129Nova-Ventrx 12Nova Medical Specialties 11Nova Technology Corp. 3Nova Medical, Inc. 1Nova Corp. 1Nova Technologies, Inc. 1Nova/Da Vinci Systems, Inc. 1Nova Design Technologies, Ltd. 1Nova Therapeutic System 1Nova Ranger, Inc. 1Nova Rubber Glove Industries Sdn. Bhd. 1