Cleared Traditional

K942378 - POCKET PUMP

K942378 is an FDA 510(k) clearance for POCKET PUMP, manufactured by Baxa Infusion Systems. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K942378 · Baxa Infusion Systems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
286d
Days
Class 2
Risk

K942378 is an FDA 510(k) clearance for the POCKET PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxa Infusion Systems (Grass Valley, US). The FDA issued a Cleared decision on March 1, 1995 after a review of 286 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 Baxa Infusion Systems devices

FDA 510(k) Submission Details - K942378

510(k) Number K942378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1994
Decision Date March 01, 1995
Days to Decision 286 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 129d · This submission: 286d
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 612
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K942378.
THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
K950419 · Imed Corp. · Jun 1995
LIFECARE 175 INFUSER, MODIFICATION
K944190 · Abbott Laboratories · May 1995
SMART DOSE(TM)
K943692 · River Medical, Inc. · Apr 1995
PLUM XL INFUSION PUMP
K944733 · Abbott Laboratories · Feb 1995
ABBOTT LTE INFUSION PUMP
K944125 · Abbott Laboratories · Dec 1994
LOCKBOX
K942161 · Pharmacia Deltec, Inc. · Aug 1994