Cleared Traditional

K862273 - BETAFLO 2000

K862273 is an FDA 510(k) clearance for BETAFLO 2000, 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 32-day FDA review.

K862273 · Betaflo, Inc. · General Hospital
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Jul 1986
Decision
32d
Days
Class 2
Risk

K862273 is an FDA 510(k) clearance for the BETAFLO 2000. 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 July 18, 1986 after a review of 32 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 - K862273

510(k) Number K862273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1986
Decision Date July 18, 1986
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 K862273.
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