Cleared Traditional

K911644 - NGM FRAME

K911644 is an FDA 510(k) clearance for NGM FRAME, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Anesthesiology device with product code CBQ cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K911644 · Datex Division Instrumentarium Corp. · Anesthesiology device
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Mar 1992
Decision
324d
Days
Class 2
Risk

K911644 is an FDA 510(k) clearance for the NGM FRAME. Classified as Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (product code CBQ), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Tewksbury, US). The FDA issued a Cleared decision on March 4, 1992 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1500 - 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. Elevated predicate reliance profile. 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 Datex Division Instrumentarium Corp. devices

FDA 510(k) Submission Details - K911644

510(k) Number K911644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1991
Decision Date March 04, 1992
Days to Decision 324 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 140d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBQ Device Classification - Class 2, Special Controls

Product Code CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1500
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 - CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)

All 16
Devices cleared under the same product code (CBQ) and FDA review panel - the closest regulatory comparables to K911644.
AS/3 COP MODULE
K922876 · Datex Division Instrumentarium Corp. · Jul 1993
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K923276 · Datex Division Instrumentarium Corp. · Jul 1993
DATASCOPE MULTINEX ID PLUS
K930303 · Datascope Corp. · Jun 1993
NGM GAS MODULE
K911647 · Datex Division Instrumentarium Corp. · Sep 1991
CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR
K903104 · Datex Division Instrumentarium Corp. · Jan 1991
ANESTHETIC AGENT MONITOR
K892854 · Criticare Systems, Inc. · Oct 1989