Cleared Traditional

K850507 - CRITIKON I.V. ADMINISTRAION SET

K850507 is an FDA 510(k) clearance for CRITIKON I.V. ADMINISTRAION SET, manufactured by Critikon Company, LLC. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K850507 · Critikon Company, LLC · General Hospital
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Mar 1985
Decision
27d
Days
Class 2
Risk

K850507 is an FDA 510(k) clearance for the CRITIKON I.V. ADMINISTRAION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on March 7, 1985 after a review of 27 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K850507

510(k) Number K850507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1985
Decision Date March 07, 1985
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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 540
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K850507.
CORRECT FLO
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