I.V. PLASTIC BAG— 510(k) K811233
Substantially EquivalentMedi-Plast Intl., Inc.
FDA 510(k) clearance K811233 for I.V. PLASTIC BAG, Substantially Equivalent on 1981-06-17. Applicant: Medi-Plast Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Medi-Plast Intl., Inc.
- Product code
- Code KPE
- Device class
- Class 2
- Regulation
- 21 CFR 880.5025
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KPE
view allMore clearances from Medi-Plast Intl., Inc.
view allAdverse events under product code KPE
product code KPE- Malfunction
- 1,000
- Other
- 1
- Total
- 1,001
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 K811233
K-number listed on FDA's recall record- Z-2639-2024 — C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
- Z-2640-2024 — Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K811233.
Data sourced from openFDA. This site is unofficial and independent of the FDA.