Cleared Traditional

K990312 - AVIA PAIN MEDICATION DELIVERY SYSTEM

K990312 is an FDA 510(k) clearance for AVIA PAIN MEDICATION DELIVERY SYSTEM, manufactured by Amtec Medical. The device is a Class 2 General Hospital device with product code MEA cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K990312 · Amtec Medical · General Hospital
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Apr 1999
Decision
80d
Days
Class 2
Risk

K990312 is an FDA 510(k) clearance for the AVIA PAIN MEDICATION DELIVERY SYSTEM. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Amtec Medical (Austin, US). The FDA issued a Cleared decision on April 22, 1999 after a review of 80 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 Amtec Medical devices

FDA 510(k) Submission Details - K990312

510(k) Number K990312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1999
Decision Date April 22, 1999
Days to Decision 80 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
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 19
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K990312.
STRYKER PAINPUMP2
K030661 · Stryker Instruments · May 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
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