510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083377Substantially Equivalent

Accupen

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

K083377 is the FDA 510(k) clearance record for ACCUPEN, a class II device, cleared for Accutome Ultrasound, Inc. on under FDA product code HKX (Tonometer, Ac-Powered). FDA records list 3 510(k) clearances for Accutome Ultrasound, Inc., from to . As of , FDA records show no recalls naming K083377.

Clearance record

Decision date
Received
(255 days to decision)
Product code
HKX Tonometer, Ac-Powered
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Accutome Ultrasound, Inc. 263 Great Valley Pkwy., Malvern PA
510(k) summary
Statement
Third party review
No

Clearances, product code HKX

Trailing 12 months
1 clearance under product code HKX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HKX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260