Cleared Traditional

K961862 - MODELS IDA-2 PLUS AND IPT-1

K961862 is the FDA 510(k) clearance for MODELS IDA-2 PLUS AND IPT-1 by Bio-Tek Instruments, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 288-day FDA review.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 129d · 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 451
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K961862.
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630
K973851 · Alexander Mfg. Co. · Jan 1998
IDA-4 AND IPT-MC
K973609 · Bio-Tek Instruments, Inc. · Dec 1997
PULSE*SPRAY INJECTOR
K963574 · AngioDynamics, Inc. · Jul 1997
GEMINI PC-ITX
K960512 · Imed Corp. · Nov 1996
CADD-PRIZM MODEL 6100 PUMP
K960826 · Sims Deltec, Inc. · Aug 1996
MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP
K955231 · Medex, Inc. · Jul 1996