Cleared Traditional

K964844 - CONMED: STAT 2 AND STAT 2 PUMPETTE EXTE...

K964844 is an FDA 510(k) clearance for CONMED: STAT 2 AND STAT 2 PUMPETTE EXTE..., manufactured by Conmedcorp. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K964844 · Conmedcorp · General Hospital
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Mar 1997
Decision
111d
Days
Class 2
Risk

K964844 is an FDA 510(k) clearance for the CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFL.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on March 24, 1997 after a review of 111 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Conmedcorp devices

FDA 510(k) Submission Details - K964844

510(k) Number K964844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1996
Decision Date March 24, 1997
Days to Decision 111 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 540
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K964844.
E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET
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INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
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NIPRO DISPOSABLE SOLUTION INFUSION SET
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SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
K964850 · Baxter Healthcare Corp · Feb 1997
VYGON BIONECTOR WITH EXTENSION SET
K963981 · Vygon Corp. · Feb 1997
POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333
K964455 · Medtronic Minimed · Jan 1997