Cleared Traditional

K942737 - POET IQ WITH FIVE AGENT CAPABILITY

K942737 is an FDA 510(k) clearance for POET IQ WITH FIVE AGENT CAPABILITY, manufactured by Criticare Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBS cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K942737 · Criticare Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
244d
Days
Class 2
Risk

K942737 is an FDA 510(k) clearance for the POET IQ WITH FIVE AGENT CAPABILITY. Classified as Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (product code CBS), Class II - Special Controls.

Submitted by Criticare Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 9, 1995 after a review of 244 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1620 - 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 Criticare Systems, Inc. devices

FDA 510(k) Submission Details - K942737

510(k) Number K942737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1994
Decision Date February 09, 1995
Days to Decision 244 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
104d slower than avg
Panel avg: 140d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBS Device Classification - Class 2, Special Controls

Product Code CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1620
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 - CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)

All 10
Devices cleared under the same product code (CBS) and FDA review panel - the closest regulatory comparables to K942737.
GAS MODULE II, MODEL 0998-00-0143
K974903 · Datascope Corp. · Mar 1998
RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR
K950101 · Marquette Electronics, Inc. · Mar 1995
AS/3 AIRWAY MODULE
K943458 · Datex Division Instrumentarium Corp. · Feb 1995
8100 ANESTHETIC AGENT MONITOR
K932389 · Biochem International, Inc. · Dec 1993
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K905754 · Datex Division Instrumentarium Corp. · Jun 1991
HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A
K896216 · Hewlett-Packard Co. · Jan 1990