Cleared Traditional

STA-SET MODEL 250 I.V. FLOW REGULATOR (K864229) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K864229 · Sta-Set Corp. · General Hospital
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Dec 1986
Decision
49d
Days
Class 2
Risk

K864229 is an FDA 510(k) clearance for the STA-SET MODEL 250 I.V. FLOW REGULATOR. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Sta-Set Corp. (Houston, US). The FDA issued a Cleared decision on December 16, 1986 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Sta-Set Corp. devices

Submission Details

510(k) Number K864229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date December 16, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDR Controller, Infusion, Intravascular, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - LDR Controller, Infusion, Intravascular, Electronic

All 11
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K864229.
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K842080 · Abbott Laboratories · Jul 1984
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K840644 · Travenol Laboratories, S.A. · Mar 1984