Cleared Traditional

K921313 - AEROSTAR

K921313 is the FDA 510(k) clearance for AEROSTAR by Biosafety Systems, Inc.. It is a Class 2 Anesthesiology device (product code CBN) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K921313 · Biosafety Systems, Inc. · Anesthesiology device
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Sep 1992
Decision
177d
Days
Class 2
Risk

K921313 is an FDA 510(k) clearance for the AEROSTAR. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Biosafety Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 177 days - an extended review cycle.

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 Biosafety Systems, Inc. devices

Submission Details

510(k) Number K921313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1992
Decision Date September 11, 1992
Days to Decision 177 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
37d slower than avg
Panel avg: 140d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K921313.
Nitronox Scavenger Plus
K223452 · Parker Hannifin Corporation · Mar 2023
Dynamic Gas Scavenging System 2 (DGSS - 2)
K193646 · Anesthetic Gas Reclamation, Inc. · Dec 2020
OPEN RESERVOIR SCAVENGER
K864034 · Draeger Medical, Inc. · Dec 1986
POSIVAC
K791127 · Vital Signs, Inc. · Jul 1979
NAD SCAVENGING RELIEF VALVE
K790333 · Draeger Medical, Inc. · Mar 1979