Cleared Traditional

K112393 - TASMAN

K112393 is the FDA 510(k) clearance for TASMAN by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K112393 · Resmed, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
89d
Days
Class 2
Risk

K112393 is an FDA 510(k) clearance for the TASMAN. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on November 16, 2011 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Resmed, Ltd. devices

Submission Details

510(k) Number K112393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2011
Decision Date November 16, 2011
Days to Decision 89 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
51d faster than avg
Panel avg: 140d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 246
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K112393.
MIRAGE QUATTRO
K113127 · Resmed, Ltd. · Jan 2012
REMSTAR AUTO A-FLEX HT
K113068 · Respironics, Inc. · Dec 2011
SWIFT FX BELLA
K112489 · Resmed, Ltd. · Dec 2011
INFOSEND GSM
K110316 · Fisher &Paykel Healthcare , Ltd. · Aug 2011
TRUBLUE NASAL MASK
K110405 · Respironics, Inc. · Jun 2011
PERFORMAX TOTAL FACE MASK
K103395 · Respironics, Inc. · Mar 2011