Cleared Traditional

K922537 - DURALIFE

K922537 is an FDA 510(k) clearance for DURALIFE, manufactured by Dhd Diemolding Healthcare Div.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K922537 · Dhd Diemolding Healthcare Div. · Anesthesiology device
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Dec 1992
Decision
190d
Days
Class 1
Risk

K922537 is an FDA 510(k) clearance for the DURALIFE. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Dhd Diemolding Healthcare Div. (Canastota, US). The FDA issued a Cleared decision on December 4, 1992 after a review of 190 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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 Dhd Diemolding Healthcare Div. devices

FDA 510(k) Submission Details - K922537

510(k) Number K922537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1992
Decision Date December 04, 1992
Days to Decision 190 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
50d slower than avg
Panel avg: 140d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

BZA Device Classification - Class 1, General Controls

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BZA Connector, Airway (extension)

All 58
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K922537.
CONNECTORS AND AIRWAY EXTENSIONS
K931036 · Life Shield Healthcare Products, Inc. · Apr 1993
CONNECTORS AND AIRWAY EXTENSIONS
K931038 · Med-Plastics Intl., Inc. · Apr 1993
MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT
K925263 · Merit Medical Systems, Inc. · Feb 1993
CATHETER MOUNTS -- MODIFICATION
K921511 · Intersurgical, Inc. · Jun 1992
ENTENDED LINE ACCESSORIES & CONNECTORS
K921512 · Intersurgical, Inc. · Jun 1992
FLEX-ELBOW
K912652 · Vital Signs, Inc. · Oct 1991