510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K936006Substantially Equivalent

Saltime Viscometer

Harold J. Kosasky, M.D., Chestnut Hill MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K936006 is the FDA 510(k) clearance record for SALTIME VISCOMETER, a class I device, cleared for Harold J. Kosasky, M.D. on under FDA product code LHZ (Viscometer, Mucus, Cervical). FDA records list one 510(k) clearance for Harold J. Kosasky, M.D. As of , FDA records show no recalls naming K936006.

Clearance record

Decision date
Received
(786 days to decision)
Product code
LHZ Viscometer, Mucus, Cervical
Regulation
21 CFR 884.1040
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Harold J. Kosasky, M.D. 25 Boylston St., Chestnut Hill MA
510(k) summary
Summary
Third party review
No

Clearances, product code LHZ

Trailing 12 months

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

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