Cleared Traditional

K013696 - SILMED NASAL SEPTAL BUTTON

K013696 · Silmed, Inc. · Ear, Nose, Throat device

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Nov 2001

Decision

21d

Days

Risk

K013696 is an FDA 510(k) clearance for the SILMED NASAL SEPTAL BUTTON. Classified as Button, Nasal Septal (product code LFB).

Submitted by Silmed, Inc. (Leesburg,, US). The FDA issued a Cleared decision on November 28, 2001 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel. 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 Silmed, Inc. devices

FDA 510(k) Submission Details - K013696

510(k) Number	K013696 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 07, 2001
Decision Date	November 28, 2001
Days to Decision	21 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

69d faster than avg

Panel avg: 90d · This submission: 21d

Pathway characteristics

Predicate-based equivalence.

LFB Device Classification - Class 0,

Product Code	LFB Button, Nasal Septal
Device Class	-

Regulatory Peers - LFB Button, Nasal Septal

All 7

Devices cleared under the same product code (LFB) and FDA review panel - the closest regulatory comparables to K013696.

BLOM-SINGER SEPTAL PERFORATION PROSTHESIS

K131745 · Helix Medical, LLC · Sep 2013

MICROMEDICS NASAL SEPTAL BUTTON

K982667 · Micromedics, Inc. · Nov 1998

NASAL SEPTAL BUTTON

K972060 · Boston Medical Products, Inc. · Jul 1997

HOOD NASAL SEPTAL BUTTON

K920994 · Hood Laboratories · May 1992

MICROTEK SEPTAL BUTTON

K862497 · Microtek Medical, Inc. · Jul 1986

NASAL SEPTAL BUTTONS

K822637 · Abco Dealers, Inc. · Sep 1982

FDA 510(k) Resources - Ear, Nose, Throat

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K013696

Silmed, Inc.

Leesburg,, IN · US

RAMA GUNDLAPALLI

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Ear, Nose, Throat

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: November 28, 2001. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

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