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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 95
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
K983705 · EMT RESUSCITATOR
Download PDF FDA Summary O-Two Systems Intl., …