Cleared Traditional

K812734 - MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P

K812734 is an FDA 510(k) clearance for MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P, manufactured by Machida America, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EQN cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K812734 · Machida America, Inc. · Ear, Nose, Throat device
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Oct 1981
Decision
20d
Days
Class 2
Risk

K812734 is an FDA 510(k) clearance for the MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P. Classified as Laryngoscope, Nasopharyngoscope (product code EQN), Class II - Special Controls.

Submitted by Machida America, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1981 after a review of 20 days - a notably fast clearance cycle.

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: 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 Machida America, Inc. devices

FDA 510(k) Submission Details - K812734

510(k) Number K812734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1981
Decision Date October 19, 1981
Days to Decision 20 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
70d faster than avg
Panel avg: 90d · This submission: 20d
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 K812734.
NAGASHIMA LIGHT SOURCE UNIT SL-5
K821709 · Kelleher Corp. · Jun 1982
NAGASHIMA NX-150F LIGHT SOURCE UNIT
K821710 · Kelleher Corp. · Jun 1982
CONPHAR LARYNGOSCOPE
K813297 · Conphar, Inc. · Jan 1982
SHILEY LOW PRESSURE THIN-CUFFED TRACH.
K792222 · Shiley, Inc. · Dec 1979
TRACH-COLLAR
K782002 · Kinetic Concepts, Inc. · Dec 1978
SHILEY CRICOTHYROTOMY TUBE
K781639 · Shiley, Inc. · Oct 1978