Cleared Traditional

K941684 - IVEX-2 EXTENSION SET WITH Y-INJECTION SITE

K941684 is an FDA 510(k) clearance for IVEX-2 EXTENSION SET WITH Y-INJECTION SITE, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K941684 · Abbott Laboratories · General Hospital
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Aug 1994
Decision
121d
Days
Class 2
Risk

K941684 is an FDA 510(k) clearance for the IVEX-2 EXTENSION SET WITH Y-INJECTION SITE. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 3, 1994 after a review of 121 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K941684

510(k) Number K941684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1994
Decision Date August 03, 1994
Days to Decision 121 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
8d faster than avg
Panel avg: 129d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPB Device Classification - Class 2, Special Controls

Product Code FPB Filter, Infusion Line
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 - FPB Filter, Infusion Line

All 65
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K941684.
0.2 U BACTERIAL FILTER
K974661 · Sims Deltec, Inc. · Feb 1998
PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
K954331 · Pall Biomedical Products Co. · Jan 1997
PHARMASSURE LARGE VOLUME TRANSFER FILTERS
K943127 · Gelman Sciences, Inc. · Sep 1994
VIAL VENT FILTER
K942275 · Gelman Sciences, Inc. · Jul 1994
EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER
K933869 · Baxter Healthcare Corp · Apr 1994
1.2 MICRON FINAL FILTER WITH EXTENSION TUBE
K940293 · Puritas Health Care, Inc. · Mar 1994