Cleared Traditional

K895426 - AMBULATORY INFUSION PUMP

K895426 is an FDA 510(k) clearance for AMBULATORY INFUSION PUMP, manufactured by Bionica, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K895426 · Bionica, Inc. · General Hospital
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Dec 1989
Decision
113d
Days
Class 2
Risk

K895426 is an FDA 510(k) clearance for the AMBULATORY INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Bionica, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on December 27, 1989 after a review of 113 days - within the typical 510(k) review window.

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 Bionica, Inc. devices

FDA 510(k) Submission Details - K895426

510(k) Number K895426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1989
Decision Date December 27, 1989
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
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 616
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K895426.
FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP
K891289 · Baxter Healthcare Corp · Feb 1990
OHMEDA 9000 SYRINGE PUMP
K896023 · Ohmeda Medical · Jan 1990
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE
K895797 · Imed Corp. · Jan 1990
BECTON DICKINSON RATE INFUSER II SYSTEM
K896593 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
MODEL 600 SYRINGE PUMP
K891237 · 3M Company · Dec 1989
BARD LIBERATOR DISPOSABLE INFUSION SYSTEM
K894292 · C.R. Bard, Inc. · Nov 1989