510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060933Substantially Equivalent

Solace Post-Operative Pain Relief Infusion System

Apex Medical Technologies, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060933 is the FDA 510(k) clearance record for SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM, a class II device, cleared for Apex Medical Technologies, Inc. on under FDA product code MEB (Pump, Infusion, Elastomeric). FDA records list 8 510(k) clearances for Apex Medical Technologies, Inc., from to . As of , FDA records show no recalls naming K060933.

Clearance record

Decision date
Received
(34 days to decision)
Product code
MEB Pump, Infusion, Elastomeric
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Apex Medical Technologies, Inc. 10064 Mesa Ridge Ct., #202, San Diego CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code MEB

Trailing 12 months
1 clearance under product code MEB in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MEB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260