Cleared Traditional

K981891 - AMBU TUBECHECK

K981891 is an FDA 510(k) clearance for AMBU TUBECHECK, manufactured by Ambu, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K981891 · Ambu, Inc. · Anesthesiology device
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Jul 1998
Decision
49d
Days
Class 2
Risk

K981891 is an FDA 510(k) clearance for the AMBU TUBECHECK. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on July 17, 1998 after a review of 49 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 Ambu, Inc. devices

FDA 510(k) Submission Details - K981891

510(k) Number K981891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1998
Decision Date July 17, 1998
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
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 133
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K981891.
RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY
K993786 · Rusch Intl. · Feb 2000
MODIFICATION TO LASER-SHIELD II
K993582 · Xomed, Inc. · Jan 2000
RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE
K990619 · Rusch Intl. · Aug 1999
T-WALL UNCUFFED TRACHEAL TUBE
K970196 · Vital Signs, Inc. · Aug 1997
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
K965132 · Mallinckrodt Medical · Mar 1997
RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY
K961837 · Rusch Intl. · Aug 1996