Cleared Traditional

K033054 - HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP

K033054 is an FDA 510(k) clearance for HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH P..., manufactured by Harvard Clinical Technology. The device is a Class 2 General Hospital device with product code MEA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K033054 · Harvard Clinical Technology · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
78d
Days
Class 2
Risk

K033054 is an FDA 510(k) clearance for the HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Harvard Clinical Technology (South Natick, US). The FDA issued a Cleared decision on December 16, 2003 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Harvard Clinical Technology devices

FDA 510(k) Submission Details - K033054

510(k) Number K033054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date December 16, 2003
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 21
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K033054.
MEDLEY PCA MODULE, MODEL 8120
K043299 · Alaris Medical Systems, Inc. · Dec 2004
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07
K043256 · Hospira, Inc. · Dec 2004
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042800 · Hospira, Inc. · Oct 2004
MEDLEY PCA MODULE, MODEL 8120
K032233 · Alaris Medical Systems, Inc. · Sep 2003
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · Baxter Healthcare Corp · Aug 2003
STRYKER PAINPUMP2
K030661 · Stryker Instruments · May 2003