Cleared Traditional

MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT (K862335) - FDA 510(k) Clearance

K862335 · U.S. Mfg. & Management, Inc. · General & Plastic Surgery device
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Jul 1986
Decision
35d
Days
-
Risk

K862335 is an FDA 510(k) clearance for the MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT.

Submitted by U.S. Mfg. & Management, Inc. (San Bernardino, US). The FDA issued a Cleared decision on July 24, 1986 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 U.S. Mfg. & Management, Inc. devices

Submission Details

510(k) Number K862335 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 19, 1986
Decision Date July 24, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -