510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K062261Substantially Equivalent

Foam Ring Port Protector

Inspired Ideas, Incorporated, Carmel IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062261 is the FDA 510(k) clearance record for FOAM RING PORT PROTECTOR, a class II device, cleared for Inspired Ideas, Incorporated on under FDA product code OBK (Port, Protector/Cushion). FDA's definition for product code OBK reads: "Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports". FDA records list one 510(k) clearance for Inspired Ideas, Incorporated. As of , FDA records show no recalls naming K062261.

Clearance record

Decision date
Received
(248 days to decision)
Product code
OBK Port, Protector/Cushion
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Applicant
Inspired Ideas, Incorporated 11460 N.Meridian St.,, Carmel IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBK

Trailing 12 months

FDA records hold no clearances under product code OBK in the trailing twelve months.

FDA records show no clearances under product code OBK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OBK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260