Cleared Traditional

HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (K033054) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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

Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K033054.
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
K051253 · Baxter Healthcare Corp · Jul 2005
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · Baxter Healthcare Corp · Aug 2003
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · Abbott Laboratories · Aug 2002
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · Baxter Healthcare Corp · Sep 2000
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K921994 · C.R. Bard, Inc. · Aug 1992
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K914502 · C.R. Bard, Inc. · Dec 1991