Cleared Traditional

K945455 - GENERAL ANESTHESIA SYSTEM

K945455 is the FDA 510(k) clearance for GENERAL ANESTHESIA SYSTEM by Vital Signs, Inc.. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K945455 · Vital Signs, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
46d
Days
Class 2
Risk

K945455 is an FDA 510(k) clearance for the GENERAL ANESTHESIA SYSTEM. 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 December 23, 1994 after a review of 46 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K945455 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received November 07, 1994
Decision Date December 23, 1994
Days to Decision 46 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 140d · This submission: 46d
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 K945455.
VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE
K960795 · Vygon Corp. · May 1996
RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE
K954585 · Rusch Intl. · May 1996
HEBELER SAFE-T-TUBE
K960450 · Boston Medical Products, Inc. · Apr 1996
ENDOPLUS
K941969 · Wembley Rubber Products (M) Sdn Bhd · Jun 1994
RAE II TRACHEAL TUBE
K941246 · Mallinckrodt Medical · Apr 1994
BIVONA ILLUMINATED ENDOTRACHEAL TUBE
K933398 · Bivona Medical Technologies · Oct 1993