Cleared Special

K983857 - AUTOVENT 1500

K983857 is an FDA 510(k) clearance for AUTOVENT 1500, manufactured by O-Two Systems Intl., Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Special 510(k) pathway after a 2-day FDA review.

K983857 · O-Two Systems Intl., Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
2d
Days
Class 2
Risk

K983857 is an FDA 510(k) clearance for the AUTOVENT 1500. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by O-Two Systems Intl., Inc. (Ontario L5s 1c8, CA). The FDA issued a Cleared decision on November 4, 1998 after a review of 2 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K983857

510(k) Number K983857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1998
Decision Date November 04, 1998
Days to Decision 2 days
Submission Type Special
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
138d faster than avg
Panel avg: 140d · This submission: 2d
Pathway characteristics
Modification to existing cleared device.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 95
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K983857.
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
K001430 · Vortran Medical Technology 1, Inc. · Jul 2000
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
K991785 · Instrumentation Industries, Inc. · Aug 1999
CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
K991195 · O-Two Systems Intl., Inc. · Apr 1999
GENESIS BLS
K983643 · O-Two Systems Intl., Inc. · Oct 1998
EMT RESUSCITATOR
K983705 · O-Two Systems Intl., Inc. · Oct 1998
AUTOVENT 1000
K983785 · O-Two Systems Intl., Inc. · Oct 1998
K983857 · AUTOVENT 1500
Download PDF FDA Summary O-Two Systems Intl., …