Cleared Traditional

K961862 - MODELS IDA-2 PLUS AND IPT-1 (FDA 510(k) Clearance)

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

K961862 · Bio-Tek Instruments, Inc. · General Hospital
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Feb 1997
Decision
288d
Days
Class 2
Risk

K961862 is an FDA 510(k) clearance for the MODELS IDA-2 PLUS AND IPT-1. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Bio-Tek Instruments, Inc. (Winooski, US). The FDA issued a Cleared decision on February 26, 1997 after a review of 288 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Bio-Tek Instruments, Inc. devices

Submission Details

510(k) Number K961862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received May 14, 1996
Decision Date February 26, 1997
Days to Decision 288 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
160d slower than avg
Panel avg: 128d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 847
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