CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS— 510(k) K964844

Clearance details

Applicant

Conmedcorp

Product code

Code FPA

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

1996-12-03

Decision date

1997-03-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Utica, NY, US

• K254123 — Ecomed Disposable Administration Sets2026-09-11
• K261530 — iiSure Infusion Set2026-06-03
• 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)2026-05-04
• K251375 — PuraCath Firefly Needleless Connector IT (9005)2026-02-12
• K251257 — nSet+ Stabilization Set [6426733] +2 more2025-12-04

• K101534 — CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM2010-11-24
• K061021 — ENTAKE STANDARD AND SAFETY PEG SYSTEM2006-04-28
• K050992 — CONMED IRRIGATION NOZZLE2005-07-14
• K050777 — PROFORMA HF 4.5 CANNULA, MODEL 050906, 0509072005-04-22
• K050304 — FX WIRE ADVANCED MEASUREMENT GUIDEWIRE2005-03-08

Death

95

Injury

14,421

Malfunction

125,815

Other

30

Total

140,361

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0805-2018 — STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) S2V-20 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/ml, 84 length, and (3) S2V-60 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/ml, 84 length) The STAT 2¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2¿ Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.Class II·Terminated·ConMed Corporation·20170619

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964844.