Cleared Traditional

K972139 - ASPR-CARE CLOSED SYSTEM

K972139 is an FDA 510(k) clearance for ASPR-CARE CLOSED SYSTEM, manufactured by Davis & Geck, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K972139 · Davis & Geck, Inc. · Anesthesiology device
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Sep 1997
Decision
89d
Days
Class 2
Risk

K972139 is an FDA 510(k) clearance for the ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHO.... Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Davis & Geck, Inc. (Hazlewood, US). The FDA issued a Cleared decision on September 3, 1997 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Davis & Geck, Inc. devices

FDA 510(k) Submission Details - K972139

510(k) Number K972139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1997
Decision Date September 03, 1997
Days to Decision 89 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
51d faster than avg
Panel avg: 140d · This submission: 89d
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 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K972139.
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
K973419 · Nellcor Puritan Bennett, Inc. · Mar 1998
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR
K973106 · Allied Healthcare Products, Inc. · Jan 1998
OHMEDA INFANT RESUSCITATION SYSTEM
K971243 · Ohmeda Medical · Dec 1997
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
K970959 · Instrumentation Industries, Inc. · Jun 1997
AMBU SPUR NEONATE
K964584 · Ambu, Inc. · May 1997
DMR/CO2 COMBO KTI
K960468 · Nellcor Puritan Bennett, Inc. · Apr 1996