Cleared Traditional

K152531 - InstaClear Lens Cleaner

K152531 is the FDA 510(k) clearance for InstaClear Lens Cleaner by Gyrus Acmi, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K152531 · Gyrus Acmi, Inc. · Ear, Nose, Throat device
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Jan 2016
Decision
134d
Days
Class 2
Risk

K152531 is an FDA 510(k) clearance for the InstaClear Lens Cleaner. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on January 15, 2016 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Gyrus Acmi, Inc. devices

Submission Details

510(k) Number K152531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2015
Decision Date January 15, 2016
Days to Decision 134 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 89d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOB Nasopharyngoscope (flexible Or Rigid)

All 85
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K152531.
PENTAX Medical ENT Video Imaging System
K162151 · Pentax of America, Inc. · Apr 2017
TIPCAM 1S 3D System
K162410 · KARL STORZ Endoscopy-America, Inc. · Mar 2017
ULTRA Telescopes
K153009 · Olympus Winter & Ibe GmbH · Apr 2016
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K132433 · Acclarent, Inc. · Apr 2014
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
K103467 · KARL STORZ Endoscopy-America, Inc. · Jun 2012
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K110097 · Acclarent, Inc. · May 2011