Cleared Traditional

K030515 - HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS

K030515 is an FDA 510(k) clearance for HANS RUDOLPH 7500 SERIES REUSABLE ORO-N..., manufactured by Hans Rudolph, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K030515 · Hans Rudolph, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
72d
Days
Class 2
Risk

K030515 is an FDA 510(k) clearance for the HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on May 2, 2003 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 - K030515

510(k) Number K030515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date May 02, 2003
Days to Decision 72 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
68d faster than avg
Panel avg: 140d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 435
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K030515.
LTV-1000 VENTILATOR
K032226 · Pulmonetic Systems, Inc. · Oct 2003
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K023366 · Datex-Ohmeda, Inc. · Oct 2003
PNEUTON VENTILATOR
K024344 · Airon Corporation · Jun 2003
OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
K023289 · Drager Medizintechnik GmbH · Jan 2003
IMAGE3 SE DISPOSABLE FULL FACE MASK
K023135 · Respironics, Inc. · Jan 2003
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
K012691 · Acutronic Medical Systems AG · Dec 2002