Cleared Traditional

K881313 - IQK-200

K881313 is an FDA 510(k) clearance for IQK-200, manufactured by Medical Repackers Co.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K881313 · Medical Repackers Co. · Anesthesiology device
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May 1988
Decision
52d
Days
Class 2
Risk

K881313 is an FDA 510(k) clearance for the IQK-200. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Medical Repackers Co. (Fort Payne, US). The FDA issued a Cleared decision on May 19, 1988 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 Medical Repackers Co. devices

FDA 510(k) Submission Details - K881313

510(k) Number K881313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date May 19, 1988
Days to Decision 52 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 140d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 189
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K881313.
CUFFED LINDER NASOTRACHEAL AIRWAY
K900457 · Polamedco, Inc. · Apr 1990
KENDALL CURITY ENDOTRACHEAL TUBES
K892432 · The Kendal Co. · Jun 1989
LINDER NASOTRACHEAL AIRWAY
K881496 · Polamedco, Inc. · May 1988
NDYAG LASER TRACHEAL TUBE
K880960 · Sheridan Catheter Corp. · Apr 1988
LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
K873461 · Mallinckrodt Critical Care · Nov 1987
NASOGASTRIC VOICETUBE
K871632 · American Omni Medical, Inc. · Sep 1987