Cleared Traditional

HRI 6500, 6600 AND 6700 SERIES V2MASKS (K071149) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071149 · Hans Rudolph, Inc. · Anesthesiology device
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Feb 2008
Decision
283d
Days
Class 2
Risk

K071149 is an FDA 510(k) clearance for the HRI 6500, 6600 AND 6700 SERIES V2MASKS. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on February 1, 2008 after a review of 283 days - an extended review 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: 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.

View all Hans Rudolph, Inc. devices

Submission Details

510(k) Number K071149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2007
Decision Date February 01, 2008
Days to Decision 283 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 140d · This submission: 283d
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 119
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K071149.
GOLIFE NASAL MASK
K102502 · Respironics, Inc. · Dec 2010
RESPIRONICS SLEEPEASY CPAP SYSTEM
K091112 · Respironics, Inc. · May 2009
COMFORTLITE NASAL MASK
K082558 · Respironics, Inc. · Mar 2009
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
K072996 · Respironics, Inc. · Dec 2007
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
K061034 · Respironics, Inc. · Jun 2006
COMFORTLITE NASAL MASK
K053352 · Respironics, Inc. · Feb 2006