Cleared Traditional

K961862 - MODELS IDA-2 PLUS AND IPT-1

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

K961862 · Bio-Tek Instruments, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K961862

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.

FRN Device Classification - Class 2, Special Controls

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 610
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K961862.
BIG BAG 3000 PRESSURE INFUSOR
K973133 · Byron Medical · Sep 1997
PULSE*SPRAY INJECTOR
K963574 · AngioDynamics, Inc. · Jul 1997
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K965230 · Abbott Mfg., Inc. · Jul 1997
DISETRONIC D-MODEM
K961975 · Disetronic Medical Systems · Jan 1997
GEMINI PC-ITX
K960512 · Imed Corp. · Nov 1996
SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/
K962709 · Sigma Intl. · Oct 1996