510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K001342Substantially Equivalent

P.o.p. Pain Kit

Post Operative Pain Management, Broadview Heights OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001342 is the FDA 510(k) clearance record for P.O.P. PAIN KIT, a class II device, cleared for Post Operative Pain Management on under FDA product code MEB (Pump, Infusion, Elastomeric). FDA records list one 510(k) clearance for Post Operative Pain Management. As of , FDA records show no recalls naming K001342.

Clearance record

Decision date
Received
(133 days to decision)
Product code
MEB Pump, Infusion, Elastomeric
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Post Operative Pain Management 1 Corporate Center, Broadview Heights OH
510(k) summary
Summary
Third party review
No

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