Cleared Traditional

K920637 - PRIME PCA AND PCA/CONTINUOUS SYSTEMS

K920637 is an FDA 510(k) clearance for PRIME PCA AND PCA/CONTINUOUS SYSTEMS, manufactured by Prime Medical Products, Inc.. The device is a Class 2 General Hospital device with product code MEA cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K920637 · Prime Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
338d
Days
Class 2
Risk

K920637 is an FDA 510(k) clearance for the PRIME PCA AND PCA/CONTINUOUS SYSTEMS. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Prime Medical Products, Inc. (Windermere, US). The FDA issued a Cleared decision on January 15, 1993 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Prime Medical Products, Inc. devices

FDA 510(k) Submission Details - K920637

510(k) Number K920637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1992
Decision Date January 15, 1993
Days to Decision 338 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 129d · This submission: 338d
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 K920637.
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