Cleared Special

K983705 - EMT RESUSCITATOR

K983705 is an FDA 510(k) clearance for EMT RESUSCITATOR, 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 8-day FDA review.

K983705 · O-Two Systems Intl., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Oct 1998
Decision
8d
Days
Class 2
Risk

K983705 is an FDA 510(k) clearance for the EMT RESUSCITATOR. 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 October 29, 1998 after a review of 8 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.

View all O-Two Systems Intl., Inc. devices

FDA 510(k) Submission Details - K983705

510(k) Number K983705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1998
Decision Date October 29, 1998
Days to Decision 8 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
132d faster than avg
Panel avg: 140d · This submission: 8d
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 63
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K983705.
CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
K991195 · O-Two Systems Intl., Inc. · Apr 1999
AUTOVENT 1500
K983857 · O-Two Systems Intl., Inc. · Nov 1998
GENESIS BLS
K983643 · O-Two Systems Intl., Inc. · Oct 1998
AUTOVENT 1000
K983785 · O-Two Systems Intl., Inc. · Oct 1998
SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
K982225 · Spiracle Technology · Oct 1998
RESPIRTECHPRO
K973975 · Vortran Medical Technology 1, Inc. · Jun 1998