STAT 2 IV PUMPETTE— 510(k) K905498

Substantially Equivalent

The Master Medical Corp.

FDA 510(k) clearance K905498 for STAT 2 IV PUMPETTE, Substantially Equivalent on 1991-04-16. Applicant: The Master Medical Corp.. Device class: 2.

Clearance details

Applicant: The Master Medical Corp.
Product code: Code LDR
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1990-12-07
Decision date: 1991-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from The Master Medical Corp.

K913076 — I.V. INSTANT TIMER1991-10-17
K905497 — MASTER FLOW I.V. PUMPETTE1991-04-16
K871753 — MASTER MEDICAL DEVICE IS I.V. STAT 21987-06-05
K852254 — I.V. STAT MASTER1985-11-18
K792560 — MASTER I.V. DIAL LOCK1979-12-20

Recalls naming K905498

K-number listed on FDA's recall record

Z-0804-2018 — STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Controller, (2) S2-12, STAT 2¿ Extension Set Gravity Flow Controller, 12 length, (3) S2-20 MD, STAT 2¿ Secondary Set Gravity Flow Controller, 20 Drops/ml, 13 length, (4) S2V-20, STAT 2¿ Primary Administration Set Gravity Flow Controller, 20 Drops/ml, 84 length, and (5) S2V-60, STAT 2¿ Primary Administration Set Gravity Flow Controller, 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 K905498.

Data sourced from openFDA. This site is unofficial and independent of the FDA.