Cleared Traditional

K831445 - INFUSION SETS #'S 124 & 142 PERSONAL

K831445 is an FDA 510(k) clearance for INFUSION SETS #'S 124 & 142 PERSONAL, manufactured by Pacesetter Systems. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K831445 · Pacesetter Systems · General Hospital
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Sep 1983
Decision
130d
Days
Class 2
Risk

K831445 is an FDA 510(k) clearance for the INFUSION SETS #'S 124 & 142 PERSONAL. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Pacesetter Systems (Walker, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 130 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 Pacesetter Systems devices

FDA 510(k) Submission Details - K831445

510(k) Number K831445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1983
Decision Date September 12, 1983
Days to Decision 130 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
1d slower than avg
Panel avg: 129d · This submission: 130d
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 789
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K831445.
INFUSION SET-52-05-1 20 DROPS-MI VOL
K833033 · Y · Nov 1983
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K833034 · Y · Nov 1983
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K833030 · Gish Biomedical, Inc. · Nov 1983
STERILE IV SET 4 SIZES
K832329 · Abco Dealers, Inc. · Aug 1983
VENIPUNCTURE VALVE
K832123 · Abbott Laboratories · Aug 1983
SOLUTION ADMIN. SETS W/FLASHBALL
K831311 · Travenol Laboratories, S.A. · Jun 1983