Cleared Traditional

K864789 - BETAFLO 2000 PIGGYBACK SYSTEM

K864789 is an FDA 510(k) clearance for BETAFLO 2000 PIGGYBACK SYSTEM, manufactured by Betaflo, Inc.. The device is a Class 2 General Hospital device with product code LDR cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K864789 · Betaflo, Inc. · General Hospital
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Feb 1987
Decision
58d
Days
Class 2
Risk

K864789 is an FDA 510(k) clearance for the BETAFLO 2000 PIGGYBACK SYSTEM. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Betaflo, Inc. (Menlo Park, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 58 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 Betaflo, Inc. devices

FDA 510(k) Submission Details - K864789

510(k) Number K864789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1986
Decision Date February 04, 1987
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDR Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K864789.
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