510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K930663Substantially Equivalent

IV Comfort Pad

D.J. Scott Mfg., Inc., Laguna Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930663 is the FDA 510(k) clearance record for IV COMFORT PAD, a class I device, cleared for D.J. Scott Mfg., Inc. on under FDA product code KMK (Device, Intravascular Catheter Securement). FDA records list one 510(k) clearance for D.J. Scott Mfg., Inc. As of , FDA records show no recalls naming K930663.

Clearance record

Decision date
Received
(233 days to decision)
Product code
KMK Device, Intravascular Catheter Securement
Regulation
21 CFR 880.5210
Device class
Class I
Review panel
General Hospital
Applicant
D.J. Scott Mfg., Inc. 23102 Terra Dr., Laguna Hills CA
510(k) summary
Statement
Third party review
No

Clearances, product code KMK

Trailing 12 months

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

FDA records show no clearances under product code KMK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMK, 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