Cleared Traditional

K915277 - ENDOTRACHEAL CPAP SET

K915277 is the FDA 510(k) clearance for ENDOTRACHEAL CPAP SET by Vital Signs, Inc.. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K915277 · Vital Signs, Inc. · Anesthesiology device
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Mar 1992
Decision
116d
Days
Class 2
Risk

K915277 is an FDA 510(k) clearance for the ENDOTRACHEAL CPAP SET. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on March 20, 1992 after a review of 116 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K915277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1991
Decision Date March 20, 1992
Days to Decision 116 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
24d faster than avg
Panel avg: 140d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 117
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K915277.
LAZER-TRACH TRACHEAL TUBE
K922894 · Sheridan Catheter Corp. · May 1993
SAFE-T-TUBE RADIOPAQUE
K930150 · Boston Medical Products, Inc. · Feb 1993
MECONIUM SUCTION DEVICE (MSD)
K914370 · Vital Signs, Inc. · Jan 1993
BIVONA SLEEP APNEA TUBE
K915799 · Bivona Medical Technologies · Feb 1992
HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM))
K912290 · Boston Medical Products, Inc. · Aug 1991
MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)
K903876 · Boston Medical Products, Inc. · Feb 1991