IV SET WITH GRADUATED CHAMBER— 510(k) K781744
Substantially EquivalentNational Patent Development Corp.
FDA 510(k) clearance K781744 for IV SET WITH GRADUATED CHAMBER, Substantially Equivalent on 1978-12-07. 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
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 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 K781744
K-number listed on FDA's recall record- Z-0621-2026 — Burette 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. BURETTE SET, 4 CARESITE LADS, STPCK 125"; Catalog Number: 490252.
- Z-0622-2026 — Burette 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. BURETTE SET W/ 2 CARESITE, 134 IN.; Catalog Number: 490159.
- Z-2547-2021 — 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
- Z-2549-2021 — Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K781744.
Data sourced from openFDA. This site is unofficial and independent of the FDA.