Cleared Special

K991195 - CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV

K991195 is an FDA 510(k) clearance for CAREVENT BLS, 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 14-day FDA review.

K991195 · 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
Apr 1999
Decision
14d
Days
Class 2
Risk

K991195 is an FDA 510(k) clearance for the CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV. 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 April 22, 1999 after a review of 14 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 - K991195

510(k) Number K991195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1999
Decision Date April 22, 1999
Days to Decision 14 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
126d faster than avg
Panel avg: 140d · This submission: 14d
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 K991195.
EMT-CPAP
K021520 · Emergency Medical Techology · Jul 2002
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
AUTOVENT 1500
K983857 · O-Two Systems Intl., Inc. · Nov 1998
GENESIS BLS
K983643 · O-Two Systems Intl., Inc. · Oct 1998
EMT RESUSCITATOR
K983705 · O-Two Systems Intl., Inc. · Oct 1998
K991195 · CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
Download PDF FDA Summary O-Two Systems Intl., …