Cleared Traditional

K851299 - CORRECT FLO

K851299 is an FDA 510(k) clearance for CORRECT FLO, manufactured by Norton Performance Plastics Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K851299 · Norton Performance Plastics Corp. · General Hospital
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May 1985
Decision
36d
Days
Class 2
Risk

K851299 is an FDA 510(k) clearance for the CORRECT FLO. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Norton Performance Plastics Corp. (Akron, US). The FDA issued a Cleared decision on May 7, 1985 after a review of 36 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 - K851299

510(k) Number K851299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date May 07, 1985
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 K851299.
IV/0165 INFUSION SET
K851336 · Infarkem Corp. · May 1985
NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)
K852140 · North American Instrument Corp. · May 1985
VIGGO ACCESSORIES FOR I.V. THERAPY
K850769 · Viggo Products · May 1985
VIGGO I.V. ACCESSORIES-VIGGO EXTENSION TUBES ETC.
K850277 · Viggo Products · Apr 1985
IVAC DRUG ADMINISTRATION DEVICE
K844843 · Y · Apr 1985
CORRECT FLO INTRAVASCULAR ADMINISTRATION SET
K850506 · Biomedical Dynamics, Inc. · Apr 1985
K851299 · CORRECT FLO
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