510(k) Report

FDA applicant

Wfr/Aquaplast Corp.

Wyckoff, NJ8 decisions1994–20120 recalls

FDA records 8 decisions for Wfr/Aquaplast Corp. (Wyckoff, NJ) from 1994 to 2012: 8 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and JAI (Couch, Radiation Therapy, Powered). 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, radiology panel, where it files most

How often FDA has decided Wfr/Aquaplast Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wfr/Aquaplast Corp. 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?

  • IYEAccelerator, Linear, Medical3decisions
  • JAICouch, Radiation Therapy, Powered2decisions
  • LZMGuard, Skin Graft1decision
  • EMACement, Dental1decision
  • EPPSplint, Nasal1decision

Who builds on its devices?

Later devices cite its devices 5 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.

  • K935067AquaplastWfr/Aquaplast Corp. · 19942cite it
  • K021124Accufix Tilting Radiotranslucent HeadholderWfr/Aquaplast Corp. · 20021cites it
  • K032156Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head Board with Shoulder Depression, Accufix…Wfr/Aquaplast Corp. · 20031cites it
  • K060671Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, VariousWfr/Aquaplast Corp. · 20061cites it

What has FDA decided for it lately?

  • K120916Qfix Radiotherapy ChairWfr/Aquaplast Corp. · 2012
  • K060671Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, VariousWfr/Aquaplast Corp. · 2006
  • K032156Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head Board with Shoulder Depression, Accufix…Wfr/Aquaplast Corp. · 2003
  • K021124Accufix Tilting Radiotranslucent HeadholderWfr/Aquaplast Corp. · 2002
  • K973370Aquaplast Palatal StentWfr/Aquaplast Corp. · 1997
  • K943871Aquaplast Tie Down DressingWfr/Aquaplast Corp. · 1994
  • K942158Aquaplast Nasal Splints, Precut Silver Splint Patterns and Splint KitsWfr/Aquaplast Corp. · 1994
  • K935067AquaplastWfr/Aquaplast Corp. · 1994

All 8 as Wfr/Aquaplast Corp. →