ELCAM STOPCOCKS AND MANIFOLDS— 510(k) K022895
Substantially EquivalentMedical Device Consultants, Inc.
FDA 510(k) clearance K022895 for ELCAM STOPCOCKS AND MANIFOLDS, Substantially Equivalent on 2002-10-18. Applicant: Medical Device Consultants, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Device Consultants, Inc.
- 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
- North Attleboro, MA, US
Recent devices under product code FMG
view allMore clearances from Medical Device Consultants, Inc.
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 K022895
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-0642-2026 — 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 numbers: 1. IV ADMIN SET, 10 DROPS/ML, 144 IN; Catalog Number: 490385. 2. IV ADMIN SET, 3 CARESITES, 120 IN.; Catalog Number: 490401.
- Z-0643-2026 — 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. NF1270A SAFELINE ANESTHESIA IV SET; Anesthesia IV Administration Set with 3 CARESITE Injection Sites and Manifold; Catalog Number: NF1270A.
- 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.
- Z-0717-2026 — 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/ 15DROPS/ML; Catalog Number: 490508.
- Z-3144-2024 — AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
- Z-0936-2020 — Y-Type Blood Set, Catalog Number 490293
- Z-0938-2020 — Y-Type Blood Set, Catalog Number 490425
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022895.
Data sourced from openFDA. This site is unofficial and independent of the FDA.