IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080— 510(k) K882302
Substantially EquivalentY
FDA 510(k) clearance K882302 for IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080, Substantially Equivalent on 1988-07-12. 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
- San Diego, CA, 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 K882302
K-number listed on FDA's recall record- Z-0350-2024 — BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.
- Z-0832-2013 — CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K882302.
Data sourced from openFDA. This site is unofficial and independent of the FDA.