Cleared Traditional

K902808 - DRIPTROL

K902808 is an FDA 510(k) clearance for DRIPTROL, manufactured by Trans-Pacific Healthcare-USA. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K902808 · Trans-Pacific Healthcare-USA · General Hospital
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Oct 1990
Decision
96d
Days
Class 2
Risk

K902808 is an FDA 510(k) clearance for the DRIPTROL. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Trans-Pacific Healthcare-USA (Naples, US). The FDA issued a Cleared decision on October 1, 1990 after a review of 96 days - within the typical 510(k) review window.

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 Trans-Pacific Healthcare-USA devices

FDA 510(k) Submission Details - K902808

510(k) Number K902808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1990
Decision Date October 01, 1990
Days to Decision 96 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
33d faster than avg
Panel avg: 129d · This submission: 96d
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 16
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K902808.
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