Cleared Traditional

K920994 - HOOD NASAL SEPTAL BUTTON

K920994 · Hood Laboratories · Ear, Nose, Throat device

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May 1992

Decision

74d

Days

Risk

K920994 is an FDA 510(k) clearance for the HOOD NASAL SEPTAL BUTTON. Classified as Button, Nasal Septal (product code LFB).

Submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on May 15, 1992 after a review of 74 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.

FDA 510(k) Submission Details - K920994

510(k) Number	K920994 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 02, 1992
Decision Date	May 15, 1992
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

16d faster than avg

Panel avg: 90d · This submission: 74d

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 8

Devices cleared under the same product code (LFB) and FDA review panel - the closest regulatory comparables to K920994.

SILMED NASAL SEPTAL BUTTON

K013696 · Silmed, Inc. · Nov 2001

MICROMEDICS NASAL SEPTAL BUTTON

K982667 · Micromedics, Inc. · Nov 1998

NASAL SEPTAL BUTTON

K972060 · Boston Medical Products, Inc. · Jul 1997

INVOTEC SEPTAL BUTTON

K901366 · Invotec International, Inc. · Jun 1990

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 K920994

Hood Laboratories

Pembroke, MA · US

LEWIS H MARTEN

Regulatory profile

19 submissions 18 cleared

95% clearance rate · Active in Ear, Nose, Throat

View all devices by Hood Laboratories →

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: May 15, 1992. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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