Cleared Traditional

K896216 - HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A

K896216 is an FDA 510(k) clearance for HEWLETT PACKARD ANESTHETIC GAS ANALYZER..., manufactured by Hewlett-Packard Co.. The device is a Class 2 Anesthesiology device with product code CBS cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K896216 · Hewlett-Packard Co. · Anesthesiology device
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Jan 1990
Decision
78d
Days
Class 2
Risk

K896216 is an FDA 510(k) clearance for the HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A. Classified as Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (product code CBS), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Germany, DE). The FDA issued a Cleared decision on January 16, 1990 after a review of 78 days - a notably fast clearance 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: 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 Hewlett-Packard Co. devices

FDA 510(k) Submission Details - K896216

510(k) Number K896216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date January 16, 1990
Days to Decision 78 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
62d faster than avg
Panel avg: 140d · This submission: 78d
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 13
Devices cleared under the same product code (CBS) and FDA review panel - the closest regulatory comparables to K896216.
8100 ANESTHETIC AGENT MONITOR
K932389 · Biochem International, Inc. · Dec 1993
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K905754 · Datex Division Instrumentarium Corp. · Jun 1991
NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR
K896629 · Nellcor, Inc. · Feb 1990
SPECTRAMED RESPIRATORY GAS ANALYZER
K873194 · Draeger Medical, Inc. · Oct 1987
NORMAC ANESTHETIC AGENT MONITOR
K832113 · Datex Division Instrumentarium Corp. · Sep 1983
SARA
K810585 · Allied Healthcare Products, Inc. · Mar 1981