Cleared Traditional

K830983 - AIRWAYS & NASOPHARYNGEAL TYPE

K830983 is an FDA 510(k) clearance for AIRWAYS & NASOPHARYNGEAL TYPE, manufactured by Medovations, Inc.. The device is a Class 1 Anesthesiology device with product code BTQ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K830983 · Medovations, Inc. · Anesthesiology device
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May 1983
Decision
41d
Days
Class 1
Risk

K830983 is an FDA 510(k) clearance for the AIRWAYS & NASOPHARYNGEAL TYPE. Classified as Airway, Nasopharyngeal (product code BTQ), Class I - General Controls.

Submitted by Medovations, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5100 - the FDA anesthesiology and respiratory 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.

FDA 510(k) Submission Details - K830983

510(k) Number K830983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1983
Decision Date May 09, 1983
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

BTQ Device Classification - Class 1, General Controls

Product Code BTQ Airway, Nasopharyngeal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BTQ Airway, Nasopharyngeal

All 18
Devices cleared under the same product code (BTQ) and FDA review panel - the closest regulatory comparables to K830983.
NASOPHARYNGEAL AIRWAYS
K841093 · Inmed Corp. · Mar 1984
SILICONE RUGGER DISPOSABLE YOKE-CPAP
K834078 · Vesta, Inc. · Dec 1983
NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE
K831476 · Fls Medical Products, Inc. · Jun 1983
NASOPHARYNGEAL AIRWAY
K810960 · Vesta, Inc. · Apr 1981
SILICONE RUBBER-BI NASOPHARYNGEAL AIR
K792018 · Vesta, Inc. · Nov 1979
AIRWAY, ARGYLE NASOPHARYNGEAL
K760125 · Sherwood Medical Industries · Jul 1976
K830983 · AIRWAYS & NASOPHARYNGEAL TYPE
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