Cleared Traditional

K883668 - SUNDERLAND NASAL TUBE

K883668 is an FDA 510(k) clearance for SUNDERLAND NASAL TUBE, manufactured by Exmoor Plastics , Ltd.. The device is a Class 1 Anesthesiology device with product code BTQ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K883668 · Exmoor Plastics , Ltd. · Anesthesiology device
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Nov 1988
Decision
87d
Days
Class 1
Risk

K883668 is an FDA 510(k) clearance for the SUNDERLAND NASAL TUBE. Classified as Airway, Nasopharyngeal (product code BTQ), Class I - General Controls.

Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on November 21, 1988 after a review of 87 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.

View all Exmoor Plastics , Ltd. devices

FDA 510(k) Submission Details - K883668

510(k) Number K883668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1988
Decision Date November 21, 1988
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 7
Devices cleared under the same product code (BTQ) and FDA review panel - the closest regulatory comparables to K883668.
POLAMEDCO NASOPAHARYNGEAL AIRWAY
K900456 · Polamedco, Inc. · Apr 1990
STERILE NASOPHARYNGEAL AIRWAY
K853162 · Inmed Corp. · Aug 1985
NASOPHARYNGEAL AIRWAY-ROBERTAZZI
K850644 · Dryden Corp. · Mar 1985
LINDER NASOPHARYNGEAL AIRWAY
K843524 · Polamedco, Inc. · Oct 1984
NASOPHARYNGEAL AIRWAYS
K841093 · Inmed Corp. · Mar 1984
AIRWAYS & NASOPHARYNGEAL TYPE
K830983 · Medovations, Inc. · May 1983