INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)— 510(k) K032393
Substantially EquivalentElcam Medical Acal
FDA 510(k) clearance K032393 for INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK), Substantially Equivalent on 2003-09-12. 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
- Traditional
- Location
- Phoenix, AZ, US
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 K032393
K-number listed on FDA's recall record- Z-0641-2026 — 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/ 10 DROPS/ML, 134 in.; Catalog Number: 490357.
- Z-0644-2026 — 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. US1295 ULTRASITE IV ADMIN SET 60DROP; Catalog Number: 352394.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032393.
Data sourced from openFDA. This site is unofficial and independent of the FDA.