Cleared Traditional

NOBLES-LAI ENGINEERING INFUSION PUMP (K895688) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895688 · Nobles-Lai Engineering, Inc. · General Hospital
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Feb 1990
Decision
157d
Days
Class 2
Risk

K895688 is an FDA 510(k) clearance for the NOBLES-LAI ENGINEERING INFUSION PUMP. Classified as Withdrawal/infusion Pump (product code DQI), Class II - Special Controls.

Submitted by Nobles-Lai Engineering, Inc. (Santa Ana, US). The FDA issued a Cleared decision on February 26, 1990 after a review of 157 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1800 - 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.

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Submission Details

510(k) Number K895688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1989
Decision Date February 26, 1990
Days to Decision 157 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
28d slower than avg
Panel avg: 129d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQI Withdrawal/infusion Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1800
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.