510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862242Substantially Equivalent

Pap Smear Kit

Quali-Med, Inc., Sugar Land TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862242 is the FDA 510(k) clearance record for PAP SMEAR KIT, a class II device, cleared for Quali-Med, Inc. on under FDA product code HHT (Spatula, Cervical, Cytological). FDA records list 7 510(k) clearances for Quali-Med, Inc., from to . As of , FDA records show no recalls naming K862242.

Clearance record

Decision date
Received
(14 days to decision)
Product code
HHT Spatula, Cervical, Cytological
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Quali-Med, Inc. 525 Julie Rivers Dr., Sugar Land TX
Third party review
No

Clearances, product code HHT

Trailing 12 months

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

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