MODIFICATION TO MALE TO MALE LUER ADAPTER— 510(k) K003712
Substantially EquivalentMolded Products, Inc.
FDA 510(k) clearance K003712 for MODIFICATION TO MALE TO MALE LUER ADAPTER, Substantially Equivalent on 2001-05-16. Applicant: Molded Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Molded Products, Inc.
- Product code
- Code KOC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Harlan, IA, US
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More clearances from Molded Products, Inc.
view allAdverse events under product code KOC
product code KOC- Death
- 4
- Total
- 4
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 K003712
K-number listed on FDA's recall record- Z-1679-2017 — Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.
- Z-0969-2013 — Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003712.
Data sourced from openFDA. This site is unofficial and independent of the FDA.