Cleared Traditional

K093495 - OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS

K093495 is an FDA 510(k) clearance for OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC ..., manufactured by American Diagnostic Corp.. The device is a Class 2 Ophthalmic device with product code HLJ cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K093495 · American Diagnostic Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
374d
Days
Class 2
Risk

K093495 is an FDA 510(k) clearance for the OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Hauppauge, US). The FDA issued a Cleared decision on November 19, 2010 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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.

FDA 510(k) Submission Details - K093495

510(k) Number K093495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2009
Decision Date November 19, 2010
Days to Decision 374 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
264d slower than avg
Panel avg: 110d · This submission: 374d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLJ Device Classification - Class 2, Special Controls

Product Code HLJ Ophthalmoscope, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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 - HLJ Ophthalmoscope, Battery-powered

All 37
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K093495.
HEINE BETA 200(R) OPHTHALMOSCOPE
K131961 · Heine Optotechnik GmbH & Co. KG · Dec 2013
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
K131719 · Medical Devices (Pvt) , Ltd. · Oct 2013
HEINE MINI 3000 LED OPHTHALMOSCOPE
K123587 · Heine Optotechnik GmbH & Co. KG · Mar 2013
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
K070270 · Kirchner & Wilhelm GmbH + Co.Kg · Nov 2007
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
K052599 · Suzhou 66 Vision-Tech Co., Ltd. · Nov 2006
OPTYSE OPHTHALMOSCOPE
K061278 · Ophthalmos , Ltd. · May 2006
K093495 · OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
Download PDF American Diagnostic C…