510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K042495Substantially Equivalent

Cumulase

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

K042495 is the FDA 510(k) clearance record for CUMULASE, a class II device, cleared for Halozyme Therapeutics, Inc. on under FDA product code MQL (Media, Reproductive). FDA records list one 510(k) clearance for Halozyme Therapeutics, Inc. As of , FDA records show no recalls naming K042495.

Clearance record

Decision date
Received
(212 days to decision)
Product code
MQL Media, Reproductive
Regulation
21 CFR 884.6180
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Halozyme Therapeutics, Inc. 11588 Sorrento Valley Rd. #17, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQL

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