Cleared Traditional

K943310 - MODEL 6100 AMBULATORY INFUSION SYSTEM

K943310 is an FDA 510(k) clearance for MODEL 6100 AMBULATORY INFUSION SYSTEM, manufactured by Pharmacia Deltec, Inc.. The device is a Class 2 General Hospital device with product code MEA cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K943310 · Pharmacia Deltec, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
225d
Days
Class 2
Risk

K943310 is an FDA 510(k) clearance for the MODEL 6100 AMBULATORY INFUSION SYSTEM. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 21, 1995 after a review of 225 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.

FDA 510(k) Submission Details - K943310

510(k) Number K943310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 11, 1994
Decision Date February 21, 1995
Days to Decision 225 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
96d slower than avg
Panel avg: 129d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEA Device Classification - Class 2, Special Controls

Product Code MEA Pump, Infusion, Pca
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 - MEA Pump, Infusion, Pca

All 30
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K943310.
PALM PUMP
K002434 · Sorenson Medical, Inc. · Aug 2000
AVIA PAIN MEDICATION DELIVERY SYSTEM
K990312 · Amtec Medical · Apr 1999
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
K982839 · Sims Deltec, Inc. · Nov 1998
VERIFUSE AMBULATORY PUMP
K934551 · Block Medical, Inc. · Mar 1994
PRIME PCA AND PCA/CONTINUOUS SYSTEMS
K920637 · Prime Medical Products, Inc. · Jan 1993
PATIENT CONTROLLED SYRINGE PUMP TYPE 3300
K915270 · Graseby Medical , Ltd. · Aug 1992
K943310 · MODEL 6100 AMBULATORY INFUSION SYSTEM
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