510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132549Substantially Equivalent

Accutip Cover

Accutome, Inc., Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132549 is the FDA 510(k) clearance record for ACCUTIP COVER, a class II device, cleared for Accutome, Inc. on under FDA product code HKY (Tonometer, Manual). FDA records list 8 510(k) clearances for Accutome, Inc., from to . As of , FDA records show no recalls naming K132549.

Clearance record

Decision date
Received
(252 days to decision)
Product code
HKY Tonometer, Manual
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Accutome, Inc. 3222 Phoenixville Pike, Malvern PA
510(k) summary
Summary PDF
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