BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100— 510(k) K013621
Substantially EquivalentBecton Dickinson Infusion Therapy Systems, Inc.
FDA 510(k) clearance K013621 for BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100, Substantially Equivalent on 2002-04-16. Applicant: Becton Dickinson Infusion Therapy Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
- 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
- Sandy, 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
More clearances from Becton Dickinson Infusion Therapy Systems, Inc.
view all- K252137 — BD Insyte IV Catheter
- K251422 — BD Saf-T-Intima Subcutaneous Catheter System
- K243403 — BD Nexiva Closed IV Catheter System
- K251155 — BD Cathena Safety IV Catheter
- K251654 — BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter
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 K013621
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013621.
Data sourced from openFDA. This site is unofficial and independent of the FDA.