Cleared Traditional

K915270 - PATIENT CONTROLLED SYRINGE PUMP TYPE 3300

K915270 is an FDA 510(k) clearance for PATIENT CONTROLLED SYRINGE PUMP TYPE 3300, manufactured by Graseby Medical , Ltd.. The device is a Class 2 General Hospital device with product code MEA cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K915270 · Graseby Medical , Ltd. · General Hospital
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Aug 1992
Decision
273d
Days
Class 2
Risk

K915270 is an FDA 510(k) clearance for the PATIENT CONTROLLED SYRINGE PUMP TYPE 3300. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Graseby Medical , Ltd. (Watford, Herts., GB). The FDA issued a Cleared decision on August 24, 1992 after a review of 273 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 Graseby Medical , Ltd. devices

FDA 510(k) Submission Details - K915270

510(k) Number K915270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1991
Decision Date August 24, 1992
Days to Decision 273 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
144d slower than avg
Panel avg: 129d · This submission: 273d
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 22
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K915270.
AVIA PAIN MEDICATION DELIVERY SYSTEM
K990312 · Amtec Medical · Apr 1999
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
K982839 · Sims Deltec, Inc. · Nov 1998
MODEL 6100 AMBULATORY INFUSION SYSTEM
K943310 · Pharmacia Deltec, Inc. · Feb 1995
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K921994 · C.R. Bard, Inc. · Aug 1992
IVAC PC ANIFUSER
K915063 · Y · Jun 1992
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K914502 · C.R. Bard, Inc. · Dec 1991