MINILOC SAFETY INFUSION SET— 510(k) K050600
Substantially EquivalentSpecialized Health Products, Intl.
FDA 510(k) clearance K050600 for MINILOC SAFETY INFUSION SET, Substantially Equivalent on 2005-05-12. Applicant: Specialized Health Products, Intl.. Device class: 2.
Clearance details
- Applicant
- Specialized Health Products, Intl.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bountiful, UT, US
Recent devices under product code FPA
view all- K254123 — Ecomed Disposable Administration Sets
- K261530 — iiSure Infusion Set
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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 K050600
K-number listed on FDA's recall record- Z-0985-2017 — MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc¿ trays per case and 160 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.
- Z-1273-2015 — BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit 20G x 0.75in with Y-Site, SafeStep Port Access Kit 20G x 1 in , SafeStep Port Access Kit 20G x 1 in with Y-Site, SafeStep Port Access Kit 19G x 0.75in , SafeStep Port Access Kit 19G x 0.75in with Y-Site, SafeStep Port Access Kit 19G x 1 in , SafeStep Port Access Kit 19G x 1 in with Y-Site, SafeStep Port Access Kit 20G x 1.5in , SafeStep Port Access Kit 20G x 1.5in with Y-Site, MiniLoc Port Access Kit 20G x 1 in, MiniLoc Port Access Kit 20G x 0.75in, MiniLoc Port Access Kit 22G x 1 in, MiniLoc Port Access Kit 22G x 0.75in, MiniLoc Port Access Kit 19G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 0.75in with Y-Site, MiniLoc Port Access Kit 22G x 1.5in with Y-Site, MiniLoc Port Access Kit 22G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in with Y-Site, PowerLoc Max Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 20G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in , PowerLoc Max Port Access Kit 20G x 1.0 in , PowerLoc Max Port Access Kit 20G x 0.75in , PowerLoc Max Port Access Kit 22G x 1.0 in , PowerLoc Max Port Access Kit 22G x 0.75in The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050600.
Data sourced from openFDA. This site is unofficial and independent of the FDA.