Cleared Traditional

K071755 - FALCK APPLANATION TONOMETER (FAT2)

K071755 is an FDA 510(k) clearance for FALCK APPLANATION TONOMETER (FAT2), manufactured by Falck Medical, Inc.. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 341-day FDA review.

K071755 · Falck Medical, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Jun 2008
Decision
341d
Days
Class 2
Risk

K071755 is an FDA 510(k) clearance for the FALCK APPLANATION TONOMETER (FAT2). Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Falck Medical, Inc. (Rockville, US). The FDA issued a Cleared decision on June 3, 2008 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Falck Medical, Inc. devices

FDA 510(k) Submission Details - K071755

510(k) Number K071755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2007
Decision Date June 03, 2008
Days to Decision 341 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 110d · This submission: 341d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKY Device Classification - Class 2, Special Controls

Product Code HKY Tonometer, Manual
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 - HKY Tonometer, Manual

All 38
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K071755.
ACCUTIP COVER
K132549 · Accutome, Inc. · Apr 2014
T-TYPE D-KAT, R-TYPE D-KAT
K133234 · Keeler Limited · Feb 2014
OCULAR FORCE GAUGE
K132917 · Ocular Therapeutix, Inc. · Dec 2013
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
K053430 · Medtronic Xomed, Inc. · Mar 2006
PROVIEW EYE PRESSURE MONITOR
K011199 · Bausch & Lomb, Inc. · Jul 2001
C.S.O. TONOMETER
K992835 · Cso · Jun 2000