CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK— 510(k) K060231
Substantially EquivalentElcam Medical Acal
FDA 510(k) clearance K060231 for CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK, Substantially Equivalent on 2006-04-13. Applicant: Elcam Medical Acal. Device class: 2.
Clearance details
- Applicant
- Elcam Medical Acal
- Product code
- Code FMG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mp. Merom Hagalil, IL
Recent devices under product code FMG
view allMore clearances from Elcam Medical Acal
view allAdverse events under product code FMG
product code FMG- Death
- 14
- Malfunction
- 3,433
- Other
- 1
- Total
- 3,448
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 K060231
K-number listed on FDA's recall record- Z-0606-2026 — Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 108 IN; Catalog Number: 490189. 2. IV ADMIN SET 137 IN.; Catalog Number: 490226.
- Z-0607-2026 — Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 132 IN; Catalog Number: 490469. 2. IV ADMIN SET, 60D 2 CARESITE VLV, 132 IN; Catalog Number: 490470.
- Z-0608-2026 — Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD. SET,15 DROPS/ML, W/EXT SET; Catalog Number: 490467.
- Z-0645-2026 — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 15DR 5CARESITE 1 ULRAPORT, 141 IN; Catalog Number: 490067.
- Z-0646-2026 — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET W/2 CARESITE & 1 ULTRAPORT ZERO; ULTRAPORT Zer0 IV Set with CARESITE; Catalog Number: 457506.
- Z-0647-2026 — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN 15D, 2 B/C VLV, 3 CARESITE LADS; Catalog Number: 490653.
- Z-0648-2026 — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ANES 15DROP W/2 CARESITE ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and high-flow ULTRAPORT stopcock; Catalog Number: 354209. 2. IV ADMIN SET W/60 DROPS/ML 106 IN.; Catalog Number: 490392. 3. IV ADMIN SET W/ 60 DROPS/ML 120 IN.; Catalog Number: 490428.
- Z-0649-2026 — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DR / mL W/ EXT SET; Catalog Number: 490208.
- Z-0650-2026 — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD SET CARESITE 127 IN. EXT SET 9 IN.; Catalog Number: 490317.
- Z-0651-2026 — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 3 CARESITE ULTRA ZERO 2/SWAB SAFE; IV Set With 3 CARESITE Injection Sites, ULTRAPORT Zer0 High-Flow, 4-Way Stopcock, and Dual Port SAFEPORT; Catalog Number: 457515.
- Z-0708-2026 — Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.; Catalog Number: 490564.
- Z-0937-2020 — Y-Type Blood Set, Catalog Number 490314
- Z-0939-2020 — Y-Type Blood Set, Catalog Number 490530
- Z-1869-2017 — Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
- Z-0987-2014 — SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060231.
Data sourced from openFDA. This site is unofficial and independent of the FDA.