510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K032967Substantially Equivalent

Pascal Dynamic Contour Tonometer

Smt Swiss Microtechnology AG, Littleton CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K032967 is the FDA 510(k) clearance record for PASCAL DYNAMIC CONTOUR TONOMETER, a class II device, cleared for Smt Swiss Microtechnology AG on under FDA product code HKY (Tonometer, Manual). FDA records list one 510(k) clearance for Smt Swiss Microtechnology AG. As of , FDA records show no recalls naming K032967.

Clearance record

Decision date
Received
(52 days to decision)
Product code
HKY Tonometer, Manual
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Smt Swiss Microtechnology AG 13 Red Fox Ln., Littleton CO
510(k) summary
Statement
Third party review
No

Clearances, product code HKY

Trailing 12 months

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

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