Cleared Traditional

K981080 - SCOOP 1

K981080 is an FDA 510(k) clearance for SCOOP 1, manufactured by Transtracheal Systems. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K981080 · Transtracheal Systems · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
85d
Days
Class 2
Risk

K981080 is an FDA 510(k) clearance for the SCOOP 1. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Transtracheal Systems (Boulder, US). The FDA issued a Cleared decision on June 17, 1998 after a review of 85 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 Transtracheal Systems devices

FDA 510(k) Submission Details - K981080

510(k) Number K981080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1998
Decision Date June 17, 1998
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
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 59
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K981080.
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
K083031 · Smiths Medical Asd, Inc. · Aug 2009
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
K021764 · Rusch Intl. · Jul 2002
CRICOTHYROTOMY TUBE
K983000 · Polamedco, Inc. · Oct 1999
CPR TRACHEOTOMY CARE TRAY
K960205 · Custom Pack Reliability · Aug 1996
MOORE TRACHEOSTOMY TUBE
K962240 · Boston Medical Products, Inc. · Aug 1996
LOW PROFILE TRACHEOSTOMY TUBE
K922749 · Concord/Portex · Sep 1992