510(k) Report

FDA applicant

Nanoplas, Inc.

Elk Grove Village, IL1 decision2012–20125 recalls

FDA records 1 decision for Nanoplas, Inc. (Elk Grove Village, IL) in 2012: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). 5 recalls are linked to its devices.

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

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

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

5in 2026

2026 (partial year): 5
2012high 5 (2026) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Nanoplas, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug1decision

What has FDA decided for it lately?

  • K112666Saline Wound WashNanoplas, Inc. · 20125 recalls

The one decision as Nanoplas, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K112666Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9%…Jan 5, 2026Class II
  • K112666Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214Jan 5, 2026Class II
  • K112666Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE…Jan 5, 2026Class II
  • K112666Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK…Jan 5, 2026Class II
  • K112666Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528Jan 5, 2026Class II