Cleared Traditional

K893532 - RESUBMITTED RADIOAEROSOL CONT. SYSTEM M...

K893532 is an FDA 510(k) clearance for RESUBMITTED RADIOAEROSOL CONT. SYSTEM M..., manufactured by Medipart Jerry Alexander. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K893532 · Medipart Jerry Alexander · Anesthesiology device
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Aug 1989
Decision
105d
Days
Class 2
Risk

K893532 is an FDA 510(k) clearance for the RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Medipart Jerry Alexander (Cary, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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 Medipart Jerry Alexander devices

FDA 510(k) Submission Details - K893532

510(k) Number K893532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1989
Decision Date August 21, 1989
Days to Decision 105 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 140d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBN Device Classification - Class 2, Special Controls

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
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 - CBN Apparatus, Gas-scavenging

All 13
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K893532.
ISO-GARD MASK
K142138 · Teleflexmedical, Inc. · Oct 2014
ISO-GARD MASK
K132729 · Teleflexmedical, Inc. · Jan 2014
ISO-GARD CLEARAIR MASK
K123176 · Teleflexmedical, Inc. · Feb 2013
OPEN RESERVOIR SCAVENGER
K864034 · Draeger Medical, Inc. · Dec 1986
GAS EVACUATION ACCESSORY
K852772 · Siemens Elema AB · Oct 1985
OHIO WASTE GAS SCAVENGING RESERVOIR
K841733 · Ohio Medical Products · Jul 1984