Cleared Traditional

K010680 - CT SPACER

K010680 is an FDA 510(k) clearance for CT SPACER, manufactured by Clinical Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K010680 · Clinical Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
77d
Days
Class 2
Risk

K010680 is an FDA 510(k) clearance for the CT SPACER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Clinical Technologies, Inc. (Barstow, US). The FDA issued a Cleared decision on May 23, 2001 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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.

FDA 510(k) Submission Details - K010680

510(k) Number K010680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2001
Decision Date May 23, 2001
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 507
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K010680.
MEDICAL DEPOT POWER NEB 1
K012006 · Medical Depot, Inc. · Jul 2001
COMOACT ULTRASONIC NEBULIZER, MODEL 3060
K002543 · San UP S.A. · Jun 2001
VEGA ULTRASONIC NEBULIZER
K002831 · Vega Technologies, Inc. · May 2001
MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
K003344 · Medical Depot, Inc. · Mar 2001
ULTRASONIC NEBULIZER, MODEL NE-520
K002153 · Medisana USA, Inc. · Mar 2001
LITEAIRE
K993101 · Thayer Medical Corp. · Oct 2000
K010680 · CT SPACER
Download PDF FDA Summary Clinical Technologies…