510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K974188Substantially Equivalent

Cetylcide-G

Kellerandheckman, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974188 is the FDA 510(k) clearance record for CETYLCIDE-G, a class II device, cleared for Kellerandheckman on under FDA product code MED (Sterilant, Medical Devices). FDA records list one 510(k) clearance for Kellerandheckman. As of , FDA records show no recalls naming K974188.

Clearance record

Decision date
Received
(307 days to decision)
Product code
MED Sterilant, Medical Devices
Regulation
21 CFR 880.6885
Device class
Class II
Review panel
General Hospital
Applicant
Kellerandheckman 1001 G St., NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code MED

Trailing 12 months
1 clearance under product code MED 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 MED, 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