INTRAVASCULAR ADMINISTRATION SET— 510(k) K820278
Substantially EquivalentY
FDA 510(k) clearance K820278 for INTRAVASCULAR ADMINISTRATION SET, Substantially Equivalent on 1982-02-18. Applicant: Y. Device class: 2.
Clearance details
- Applicant
- Y
- 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
view all- K254123 — Ecomed Disposable Administration Sets
- K261530 — iiSure Infusion Set
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Y
view all- K955846 — MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
- K960280 — IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
- K953225 — IVAC BALL VALCE ADMIN. SETS
- K934095 — IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS
- K940897 — IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET
Adverse 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 K820278
K-number listed on FDA's recall record- Z-2458-2021 — BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
- Z-2281-2013 — CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K820278.
Data sourced from openFDA. This site is unofficial and independent of the FDA.