Cleared Traditional

K843249 - T-TYPE IV EXTENSION SET

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

K843249 · Strato Medical Corp. · General Hospital
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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.

FDA 510(k) Submission Details - K843249

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.

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 1177
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K843249.
IVAC C80014 Y SOLUTION ADMIN. SET
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K842858 · Norton Performance Plastics Corp. · Sep 1984
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K842088 · Venusa , Ltd. · Aug 1984
ACCESS. TO INTERAVACULAR ADMIN. SET
K842657 · Tanner Corp. · Aug 1984
T- EXTENSION SET T-04-C
K842985 · Tico Medical Instruments, Inc. · Aug 1984
K843249 · T-TYPE IV EXTENSION SET
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