I.V. ADMINISTRATION SET WITH MINI-SPIKE— 510(k) K780551
Substantially EquivalentNational Patent Development Corp.
FDA 510(k) clearance K780551 for I.V. ADMINISTRATION SET WITH MINI-SPIKE, Substantially Equivalent on 1978-04-19. Applicant: National Patent Development Corp.. Device class: 2.
Clearance details
- Applicant
- National Patent Development Corp.
- 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
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code FPA
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- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from National Patent Development Corp.
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 K780551
K-number listed on FDA's recall record- Z-0128-2024 — FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
- Z-0129-2024 — SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K780551.
Data sourced from openFDA. This site is unofficial and independent of the FDA.