Cleared Traditional

K771551 - I.V. PREP & CARE KIT

K771551 is an FDA 510(k) clearance for I.V. PREP & CARE KIT, manufactured by Jelco Laboratories. The device is a Class 1 General Hospital device with product code FRL cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K771551 · Jelco Laboratories · General Hospital
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Oct 1977
Decision
53d
Days
Class 1
Risk

K771551 is an FDA 510(k) clearance for the I.V. PREP & CARE KIT. Classified as Fiber, Medical, Absorbent (product code FRL), Class I - General Controls.

Submitted by Jelco Laboratories (Mchenry, US). The FDA issued a Cleared decision on October 4, 1977 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5300 - 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 Jelco Laboratories devices

FDA 510(k) Submission Details - K771551

510(k) Number K771551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1977
Decision Date October 04, 1977
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

FRL Device Classification - Class 1, General Controls

Product Code FRL Fiber, Medical, Absorbent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.