Cleared Traditional

K083377 - ACCUPEN

K083377 is an FDA 510(k) clearance for ACCUPEN, manufactured by Accutome Ultrasound, Inc.. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K083377 · Accutome Ultrasound, Inc. · Ophthalmic device
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Jul 2009
Decision
255d
Days
Class 2
Risk

K083377 is an FDA 510(k) clearance for the ACCUPEN. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Accutome Ultrasound, Inc. (Malvern, US). The FDA issued a Cleared decision on July 27, 2009 after a review of 255 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Accutome Ultrasound, Inc. devices

FDA 510(k) Submission Details - K083377

510(k) Number K083377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2008
Decision Date July 27, 2009
Days to Decision 255 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 110d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKX Device Classification - Class 2, Special Controls

Product Code HKX Tonometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HKX Tonometer, Ac-powered

All 28
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K083377.
Keeler TonoCare Tonometer
K181143 · Keeler Instruments, Inc. · Feb 2019
Tono Vue Non-Contact Tonometer
K180820 · Crystalvue Medical Corporation · Dec 2018
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
K093298 · Keeler Instruments, Inc. · Dec 2010
KOWA KT-800
K053444 · Kowa Co. , Ltd. · Jun 2006
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · Nidek, Inc. · Dec 2003
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · Xomed, Inc. · Dec 2000