Cleared Traditional

INTRAVENOUS START KIT (K843813) - FDA 510(k) Clearance

K843813 · Pro-Lab, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1984
Decision
68d
Days
-
Risk

K843813 is an FDA 510(k) clearance for the INTRAVENOUS START KIT.

Submitted by Pro-Lab, Inc. (Round Rock, US). The FDA issued a Cleared decision on December 5, 1984 after a review of 68 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 Pro-Lab, Inc. devices

Submission Details

510(k) Number K843813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1984
Decision Date December 05, 1984
Days to Decision 68 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
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -