Cleared Traditional

K946077 - DIRECTIONAL CONTROL VALVES INFLATABLE B...

K946077 is an FDA 510(k) clearance for DIRECTIONAL CONTROL VALVES INFLATABLE B..., manufactured by Hans Rudolph, Inc.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K946077 · Hans Rudolph, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
276d
Days
Class 2
Risk

K946077 is an FDA 510(k) clearance for the DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 276 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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 - K946077

510(k) Number K946077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1994
Decision Date September 15, 1995
Days to Decision 276 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 140d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 28
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K946077.
CO 2 SMO PLUS
K963380 · Novametrix Medical Systems, Inc. · Jan 1997
VENTRAK RMMS 1550
K960831 · Novametrix Medical Systems, Inc. · May 1996
ACKRAD ESOPHAGEAL BALLOON CATHETER SET
K952542 · Ackrad Laboratories · Apr 1996
SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART
K915833 · Sensor Medics Corp. · Dec 1992
MODEL 2900 METABOLIC MEASUREMENT CART
K915686 · Sensor Medics Corp. · Dec 1992
MODIFIED STAR CALC
K895963 · Infrasonics Corp. · Mar 1990