Cleared Traditional

K971243 - OHMEDA INFANT RESUSCITATION SYSTEM

K971243 is an FDA 510(k) clearance for OHMEDA INFANT RESUSCITATION SYSTEM, manufactured by Ohmeda Medical. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K971243 · Ohmeda Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
243d
Days
Class 2
Risk

K971243 is an FDA 510(k) clearance for the OHMEDA INFANT RESUSCITATION SYSTEM. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on December 2, 1997 after a review of 243 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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 Ohmeda Medical devices

FDA 510(k) Submission Details - K971243

510(k) Number K971243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1997
Decision Date December 02, 1997
Days to Decision 243 days
Submission Type Traditional
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
103d slower than avg
Panel avg: 140d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 127
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K971243.
PLUS REUSABLE RESUSCITATOR
K974141 · Schiff & Co. · May 1998
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
K973419 · Nellcor Puritan Bennett, Inc. · Mar 1998
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR
K973106 · Allied Healthcare Products, Inc. · Jan 1998
MERCURY MEDICAL REUSABLE CPR BAG
K970756 · Mercury Medical · Oct 1997
SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT
K972283 · Sims · Sep 1997
ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
K972139 · Davis & Geck, Inc. · Sep 1997