Cleared Traditional

K843249 - T-TYPE IV EXTENSION SET

K843249 is the FDA 510(k) clearance for T-TYPE IV EXTENSION SET by Strato Medical Corp.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K843249 · Strato Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1984
Decision
18d
Days
Class 2
Risk

K843249 is an FDA 510(k) clearance for the T-TYPE IV EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Strato Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984 after a review of 18 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Strato Medical Corp. devices

Submission Details

510(k) Number K843249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1984
Decision Date September 07, 1984
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 467
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K843249.
MINISET VEIN INFUSION SETS
K843631 · Travenol Laboratories, S.A. · Oct 1984
IVAC C80014 Y SOLUTION ADMIN. SET
K843185 · Y · Sep 1984
FLUID ADMINISTRATION LINE W/SPIKE 14-923
K842858 · Norton Performance Plastics Corp. · Sep 1984
SYRINGE ADDITIVE IV ADMIN. SETS
K841361 · Quest Medical, Inc. · May 1984
HARVARD ANTI-REFLUX Y-SET
K840760 · C.R. Bard, Inc. · Apr 1984
QUIK LOK
K840878 · Abbott Laboratories · Mar 1984