SAFEPORT MANIFOLD (TM) (OR STOPCOCK)— 510(k) K111016
Substantially EquivalentElcam Medical Acal
FDA 510(k) clearance K111016 for SAFEPORT MANIFOLD (TM) (OR STOPCOCK), Substantially Equivalent on 2011-06-09. Applicant: Elcam Medical Acal. Device class: 2.
Clearance details
- Applicant
- Elcam Medical Acal
- 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
- Special
- Location
- Mp. Merom Hagalil, IL
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More clearances from Elcam Medical Acal
view allAdverse 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 K111016
K-number listed on FDA's recall record- Z-0629-2026 — Extension 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. ANES SET W/DUAL FEM.LL SAFEPORT MANIFOLD; Catalog Number: 456520.
- Z-0631-2026 — Extension 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. EXTENSION SET, 25 IN.; Catalog Number: 490629.
- Z-0635-2026 — Extension 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. EXT SET ULTRAPORT STOPCOCK, 37IN.; Catalog Number: 490234.
- Z-0637-2026 — Extension 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 numbers: 1. ANESTHESIA SET W/ SAFEPORT MANIFOLD; Catalog Number: 456521. 2. ANES SET W/TRIPLE LL SAFEPORT MANIFOLD; Catalog Number: 456522.
- Z-0656-2026 — 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 DROPS/ML 126 IN; Catalog Number: 490283.
- Z-0664-2026 — 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, 15 DR/ML,2 CARESITE,146 IN; Catalog Number: 490315. 2. IV ADMN SET,2 CARESITE, SAFEPORT,129 IN.; Catalog Number: 490331. 3. IV ADMIN SET 15 DROPS/ML, CARESITE,98 IN; Catalog Number: 490376.
- Z-0665-2026 — 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 15DR, 92 IN W/EXT SET 9 IN.; Catalog Number: 490489.
- Z-0693-2026 — 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 DROPS/ML 115 in.; Catalog Number: 490354.
- Z-0695-2026 — 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 15DR HF 4-WAY STPCK 135 IN.; Catalog Number: 490193. 2. IV AD SET, 2 CARESITE, SAFEPORT, 134 IN.; Catalog Number: 490326.
- Z-0696-2026 — 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 DROPS/ML, 118 IN.; Catalog Number: 490437.
- Z-0699-2026 — 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 103 IN.; Catalog Number: 490239.
- Z-3144-2024 — AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111016.
Data sourced from openFDA. This site is unofficial and independent of the FDA.