Cleared Traditional

K820099 - TRACH TAPE

K820099 is the FDA 510(k) clearance for TRACH TAPE by Stan-Pak Ent.. It is a Class 2 Anesthesiology device (product code BTO) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K820099 · Stan-Pak Ent. · Anesthesiology device
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Feb 1982
Decision
41d
Days
Class 2
Risk

K820099 is an FDA 510(k) clearance for the TRACH TAPE. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Stan-Pak Ent. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1982 after a review of 41 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 Stan-Pak Ent. devices

Submission Details

510(k) Number K820099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1982
Decision Date February 23, 1982
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 41
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K820099.
H.R. JAKOBI SURG. INSTRUMENTS #9 48
K834179 · Imm Enterprises , Ltd. · Jan 1984
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW
K831720 · Sherwood Medical Co. · Jul 1983
CONTAINERS OF STERILE WATER OS SALINE
K822811 · American Pharmaseal Div. Ahsc · Oct 1982
SHILEY DISPOSABLE CANNULA TRACH. TUBE
K811447 · Shiley, Inc. · Jun 1981
SHILEY LOW PRESSURE THIN-CUFFED TRACH
K811033 · Shiley, Inc. · May 1981
MONTGOMERY SILICONE TRACHEAL T-TUBE
K810978 · Boston Medical Products, Inc. · May 1981