Cleared Traditional

BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE (K897005) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K897005 · Helix Medical, Inc. · Anesthesiology device
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Mar 1990
Decision
88d
Days
Class 2
Risk

K897005 is an FDA 510(k) clearance for the BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Helix Medical, Inc. (Santa Barbera, US). The FDA issued a Cleared decision on March 16, 1990 after a review of 88 days - a notably fast clearance cycle.

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: 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 Helix Medical, Inc. devices

Submission Details

510(k) Number K897005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1989
Decision Date March 16, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOH Tube Tracheostomy And Tube Cuff
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 - JOH Tube Tracheostomy And Tube Cuff

All 20
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K897005.
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
K072148 · Cook, Inc. · Oct 2007
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
K041044 · Cook, Inc. · Jul 2004
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K903435 · Shiley, Inc. · Oct 1990
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K890194 · Shiley, Inc. · Jul 1989
SHILEY FENESTRATED LOW PRESS. CUFFED
K812302 · Shiley, Inc. · Sep 1981