Cleared Traditional

K897005 - BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE

K897005 is an FDA 510(k) clearance for BLOM-SINGER SILICONE LARYNGECTOMY TUBE, manufactured by Helix Medical, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 88-day FDA review.

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

FDA 510(k) Submission Details - K897005

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.

JOH Device Classification - Class 2, Special Controls

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 86
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K897005.
BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.
K912967 · Bivona Medical Technologies · Jul 1991
TRACHEOSTOMY CARE KIT
K910362 · Megadyne Medical Products, Inc. · Apr 1991
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K903435 · Shiley, Inc. · Oct 1990
HOOD SPEAKING VALVE
K897059 · Hood Laboratories · Mar 1990
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K896547 · Bivona Medical Technologies · Jan 1990
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K896548 · Bivona Medical Technologies · Jan 1990