Cleared Traditional

K020759 - 7600 SERIES REUSABLE FULL-FACE CPAP/NIP...

K020759 is an FDA 510(k) clearance for 7600 SERIES REUSABLE FULL-FACE CPAP/NIP..., manufactured by Hans Rudolph, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K020759 · Hans Rudolph, Inc. · Anesthesiology device
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Aug 2002
Decision
159d
Days
Class 2
Risk

K020759 is an FDA 510(k) clearance for the 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIU.... 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 August 13, 2002 after a review of 159 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

FDA 510(k) Submission Details - K020759

510(k) Number K020759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2002
Decision Date August 13, 2002
Days to Decision 159 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
19d slower than avg
Panel avg: 140d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

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 307
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K020759.
MIRAGE FULL FACE MASK SERIES 2
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MIRAGE FULL FACE MASK SERIES 2
K023284 · Resmed, Ltd. · Nov 2002
MIRAGE FULL FACE MASK SERIES 2
K023306 · Resmed, Ltd. · Nov 2002
IQ NASAL MASK, MODEL 50160 REV. D
K021534 · Sleepnet Corporation · Jul 2002
REMSTAR PRO WITH C-FLEX CPAP SYSTEM
K021861 · Respironics, Inc. · Jun 2002
ORION NASAL CPAP SYSTEM
K020730 · Bird Products Corp. · May 2002