Cleared Traditional

K955461 - TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).

K955461 is an FDA 510(k) clearance for TRANSTRACHEAL CATHETER (ACC. RAVUSSIN)., manufactured by VBM Medizintechnik GmbH. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 476-day FDA review.

K955461 · VBM Medizintechnik GmbH · Anesthesiology device
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Mar 1997
Decision
476d
Days
Class 2
Risk

K955461 is an FDA 510(k) clearance for the TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by VBM Medizintechnik GmbH (Roy, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 476 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all VBM Medizintechnik GmbH devices

FDA 510(k) Submission Details - K955461

510(k) Number K955461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1995
Decision Date March 19, 1997
Days to Decision 476 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
336d slower than avg
Panel avg: 140d · This submission: 476d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 65
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K955461.
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
K021764 · Rusch Intl. · Jul 2002
CRICOTHYROTOMY TUBE
K983000 · Polamedco, Inc. · Oct 1999
SCOOP 1
K981080 · Transtracheal Systems · Jun 1998
CPR TRACHEOTOMY CARE TRAY
K960205 · Custom Pack Reliability · Aug 1996
MOORE TRACHEOSTOMY TUBE
K962240 · Boston Medical Products, Inc. · Aug 1996
LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
K953559 · Seidel Medizin GmbH · May 1996