SALINE WOUND WASH— 510(k) K112666
Substantially EquivalentNanoplas, Inc.
FDA 510(k) clearance K112666 for SALINE WOUND WASH, Substantially Equivalent on 2012-04-20. Applicant: Nanoplas, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Nanoplas, Inc.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elk Grove Village, IL, US
Recent devices under product code FRO
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K112666
K-number listed on FDA's recall record- Z-1431-2026 — Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
- Z-1432-2026 — Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
- Z-1433-2026 — Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1
- Z-1434-2026 — Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
- Z-1435-2026 — Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112666.
Data sourced from openFDA. This site is unofficial and independent of the FDA.