Cleared Traditional

K871632 - NASOGASTRIC VOICETUBE

K871632 is an FDA 510(k) clearance for NASOGASTRIC VOICETUBE, manufactured by American Omni Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K871632 · American Omni Medical, Inc. · Anesthesiology device
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Sep 1987
Decision
142d
Days
Class 2
Risk

K871632 is an FDA 510(k) clearance for the NASOGASTRIC VOICETUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by American Omni Medical, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on September 16, 1987 after a review of 142 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Omni Medical, Inc. devices

FDA 510(k) Submission Details - K871632

510(k) Number K871632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1987
Decision Date September 16, 1987
Days to Decision 142 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
2d slower than avg
Panel avg: 140d · This submission: 142d
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 157
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K871632.
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
AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE
K872366 · Bivona Medical Technologies · Aug 1987
BELL/MCKAY TRACHEAL TUBE
K872616 · Sheridan Catheter Corp. · Aug 1987
EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
K870387 · American Pharmaseal Div. Ahsc · May 1987