Cleared Traditional

K060933 - SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM

K060933 is an FDA 510(k) clearance for SOLACE POST-OPERATIVE PAIN RELIEF INFUS..., manufactured by Apex Medical Technologies, Inc.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K060933 · Apex Medical Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
34d
Days
Class 2
Risk

K060933 is an FDA 510(k) clearance for the SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Apex Medical Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on May 9, 2006 after a review of 34 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 Apex Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K060933

510(k) Number K060933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2006
Decision Date May 09, 2006
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
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 - MEB Pump, Infusion, Elastomeric

All 52
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K060933.
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · Baxter Healthcare Corp · May 2007
ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
K063530 · I-Flow Corp. · Jan 2007
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
K062457 · Baxter Healthcare Corporation · Sep 2006
SEMPERFLO INFUSION SYSTEM
K052999 · Ethicon, Inc. · Mar 2006
NIPRO SUREFUSER AMBULATORY INFUSION PUMP
K051828 · Nipro Medical Corporation · Dec 2005
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
K052117 · I-Flow Corp. · Sep 2005