Cleared Traditional

K131881 - OMBRA TABLE TOP COMPRESSOR

K131881 is an FDA 510(k) clearance for OMBRA TABLE TOP COMPRESSOR, manufactured by Trudell Medical Intl.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K131881 · Trudell Medical Intl. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
121d
Days
Class 2
Risk

K131881 is an FDA 510(k) clearance for the OMBRA TABLE TOP COMPRESSOR. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Trudell Medical Intl. (London, CA). The FDA issued a Cleared decision on October 24, 2013 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K131881

510(k) Number K131881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2013
Decision Date October 24, 2013
Days to Decision 121 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
19d faster than avg
Panel avg: 140d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTI Device Classification - Class 2, Special Controls

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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 - BTI Compressor, Air, Portable

All 45
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K131881.
MEDICAL AIR COMPRESSOR
K113338 · Oricare, Inc. · Aug 2012
DK50 DS
K091871 · Ekom S.R.O. · Oct 2009
EMG TRITON -COMP,MODEL NCA01-XXX SERIES
K072634 · Emg Technology Co., Ltd. · Nov 2008
MEDICAL COMPRESSOR, MODELS DK50 D AND DM
K060781 · Ekom S.R.O. · Oct 2006
MINIMATE COMPRESSOR
K051691 · Precision Medical, Inc. · Dec 2005
VENTILAIR II MEDICAL AIR COMPRESSOR
K041781 · Hamilton Medical AG · Mar 2005