Cleared Traditional

K963481 - ANODYNE CC

K963481 is an FDA 510(k) clearance for ANODYNE CC, manufactured by Heyer America, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K963481 · Heyer America, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
342d
Days
Class 2
Risk

K963481 is an FDA 510(k) clearance for the ANODYNE CC. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Heyer America, Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on August 11, 1997 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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. Elevated predicate reliance profile. 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 Heyer America, Inc. devices

FDA 510(k) Submission Details - K963481

510(k) Number K963481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date August 11, 1997
Days to Decision 342 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
202d slower than avg
Panel avg: 140d · This submission: 342d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 131
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K963481.
NARKOMED MRI ANESTHESIA SYSTEM
K972848 · Draeger Medical, Inc. · Oct 1997
HP ORVUE INTRA-OP (M2510A)
K965160 · Hewlett-Packard GmbH · Sep 1997
NARKOMED M ANESTHESIA SYSTEM (M)
K971425 · Draeger Medical, Inc. · Sep 1997
OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
K965041 · Ohmeda Medical · Jun 1997
NARKOMED GS ANESTHESIA SYSTEM
K963994 · Draeger Medical, Inc. · Mar 1997
OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
K946127 · Ohmeda Medical · Oct 1996