Cleared Traditional

K821013 - IVEX-HP PEDIATRIC EXTENSION SET-SL

K821013 is an FDA 510(k) clearance for IVEX-HP PEDIATRIC EXTENSION SET-SL, 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 109-day FDA review.

K821013 · Abbott Laboratories · General Hospital
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Jul 1982
Decision
109d
Days
Class 2
Risk

K821013 is an FDA 510(k) clearance for the IVEX-HP PEDIATRIC EXTENSION SET-SL. 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 July 30, 1982 after a review of 109 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 - K821013

510(k) Number K821013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1982
Decision Date July 30, 1982
Days to Decision 109 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 129d · This submission: 109d
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 K821013.
TRILEX
K831315 · Tri-Med, Inc. · Aug 1983
IVFLO-HP & IVFIL-HP FILTER
K831350 · Tri-Med, Inc. · Aug 1983
IVFLO-HP & IVFIL-HP
K823690 · Tri-Med, Inc. · Dec 1982
IV FILTERSET 5 MICROMETER
K813445 · Imed Corp. · Jan 1982
IV FILTERSET 0.22 MICROMETER
K813446 · Imed Corp. · Jan 1982
FIBRI-FILTER 20
K813001 · Tri-Med, Inc. · Nov 1981