Cleared Traditional

IVEX-HP PEDIATRIC EXTENSION SET-SL (K821013) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 25
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K821013.
AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER
K860746 · Travenol Laboratories, S.A. · Apr 1986
IVEX-INT
K833684 · Abbott Laboratories · Dec 1983
CONTINU-FLO SOLUTION ADMINISTRATION
K831668 · Travenol Laboratories, S.A. · Aug 1983
TERFUSION FINAL FILTER SET
K810113 · Terumo Medical Corp. · Mar 1981
B-D FILTER NEEDLE
K801343 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980
BIOGUARD INFUSION LINE FILTER
K791822 · United States Surgical, A Division of Tyco Healthc · Nov 1979