510(k) Report

FDA applicant

M-Pact Worldwide Management Corp.

Eudora, KS3 decisions1996–19972 recalls

FDA records 3 decisions for M-Pact Worldwide Management Corp. (Eudora, KS) from 1996 to 1997: 3 510(k) clearances. Most are in product codes HOZ (Sponge, Ophthalmic) and EMX (Balloon, Epistaxis). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

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

How often FDA has decided M-Pact Worldwide Management Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for M-Pact Worldwide Management Corp. since 2007.

Recalls per year

2in 2024

2024: 2
2007high 2 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — M-Pact Worldwide Management 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?

  • HOZSponge, Ophthalmic1decision
  • EMXBalloon, Epistaxis1decision
  • GECBrush, Scrub, Operating-Room1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K971832Ivalon Pva Surgical Spear, Ivalon Eye Drain, 80CC, Ivalon Eye Drain, 400CC, Ivalon Eye WickM-Pact Worldwide Management Corp. · 19972 recalls
  • K971473Ivalon Instrument Wipe, Ivalon Knife Cleaning BlockM-Pact Worldwide Management Corp. · 1997
  • K964113Ivalon Nasal Packing W/Drawstring (8.0CM & 4.5CM), Ivalon Nasal Packing W/Airway Tube & Drawstring, Ivalon…M-Pact Worldwide Management Corp. · 1996

All 3 as M-Pact Worldwide Management Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K971832Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from…Oct 22, 2024Class II
  • K971832Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical…Oct 22, 2024Class II