Cleared Traditional

I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI (K853242) - FDA 510(k) Clearance

K853242 · U.S. Mfg. & Management, Inc. · General & Plastic Surgery device
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Aug 1985
Decision
29d
Days
-
Risk

K853242 is an FDA 510(k) clearance for the I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI.

Submitted by U.S. Mfg. & Management, Inc. (San Bernardino, US). The FDA issued a Cleared decision on August 30, 1985 after a review of 29 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 K853242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received August 01, 1985
Decision Date August 30, 1985
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -