Cleared Traditional

K053430 - TONO-PEN AVIA TONOMETER AND OCU-SHILED ...

K053430 is an FDA 510(k) clearance for TONO-PEN AVIA TONOMETER AND OCU-SHILED ..., manufactured by Medtronic Xomed, Inc.. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K053430 · Medtronic Xomed, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
84d
Days
Class 2
Risk

K053430 is an FDA 510(k) clearance for the TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 3, 2006 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Xomed, Inc. devices

FDA 510(k) Submission Details - K053430

510(k) Number K053430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2005
Decision Date March 03, 2006
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
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 17
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K053430.
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K011199 · Bausch & Lomb, Inc. · Jul 2001
SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE
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JAKOBI SURG. INSTRUMENTS #6 50
K834187 · Imm Enterprises , Ltd. · Mar 1984