Cleared Traditional

K071755 - FALCK APPLANATION TONOMETER (FAT2) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071755 · Falck Medical, Inc. · Ophthalmic device
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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

Submission Details

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.

Device Classification

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 55
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K071755.
iCare ST500 (TA04)
K241447 · Icare Finland OY · Sep 2024
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
K233516 · Reichert, Inc. · May 2024
CATS-L Tonometer™ Prism
K234037 · Cats Tonometer, LLC · Feb 2024
Applanation Tonometer HT-5000
K232143 · Huvitz Co., Ltd. · Oct 2023
iCare IC200
K220852 · Icare Finland OY · Oct 2022
iCare HOME2
K211355 · Icare Finland OY · Jan 2022