Cleared Traditional

K893693 - H.U. I.V. DROP COUNTER

K893693 is an FDA 510(k) clearance for H.U. I.V. DROP COUNTER, manufactured by Li-Lien Corp.. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K893693 · Li-Lien Corp. · General Hospital
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Oct 1989
Decision
164d
Days
Class 2
Risk

K893693 is an FDA 510(k) clearance for the H.U. I.V. DROP COUNTER. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Li-Lien Corp. (San Jose, US). The FDA issued a Cleared decision on October 27, 1989 after a review of 164 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2420 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Li-Lien Corp. devices

FDA 510(k) Submission Details - K893693

510(k) Number K893693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1989
Decision Date October 27, 1989
Days to Decision 164 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
35d slower than avg
Panel avg: 129d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLN Device Classification - Class 2, Special Controls

Product Code FLN Monitor, Electric For Gravity Flow Infusion Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2420
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 - FLN Monitor, Electric For Gravity Flow Infusion Systems

All 21
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