Cleared Traditional

K831255 - LARYNGOSCOPE ATTACHMENT PH2000

K831255 is an FDA 510(k) clearance for LARYNGOSCOPE ATTACHMENT PH2000, manufactured by Eder Instrument Co, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EQN cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K831255 · Eder Instrument Co, Inc. · Ear, Nose, Throat device
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Sep 1983
Decision
147d
Days
Class 2
Risk

K831255 is an FDA 510(k) clearance for the LARYNGOSCOPE ATTACHMENT PH2000. Classified as Laryngoscope, Nasopharyngoscope (product code EQN), Class II - Special Controls.

Submitted by Eder Instrument Co, Inc. (Milwaukee, Wi 53202, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 147 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 Eder Instrument Co, Inc. devices

FDA 510(k) Submission Details - K831255

510(k) Number K831255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1983
Decision Date September 12, 1983
Days to Decision 147 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 90d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EQN Device Classification - Class 2, Special Controls

Product Code EQN Laryngoscope, Nasopharyngoscope
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 - EQN Laryngoscope, Nasopharyngoscope

All 15
Devices cleared under the same product code (EQN) and FDA review panel - the closest regulatory comparables to K831255.
ORL Video NasoPharyngo-Larngoscope
K150248 · Jedmed Instrument Company · Jul 2015
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
K132039 · Jedmed Instrument Co. · Feb 2014
OP-CON SURG. INSTRUMENT #7
K834172 · Imm Enterprises , Ltd. · Mar 1984
LARYNGOSCOPES RIGID
K822525 · Kelleher Corp. · Sep 1982
NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL
K821706 · Kelleher Corp. · Jun 1982
NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT
K821707 · Kelleher Corp. · Jun 1982