Cleared Traditional

K925910 - HEWLETT-PACKARD MODEL M1018A TCPO2/TOPC...

K925910 is the FDA 510(k) clearance for HEWLETT-PACKARD MODEL M1018A TCPO2/TOPC... by Hewlett-Packard Co.. It is a Class 2 Anesthesiology device (product code KLK) cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K925910 · Hewlett-Packard Co. · Anesthesiology device
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Jul 1993
Decision
248d
Days
Class 2
Risk

K925910 is an FDA 510(k) clearance for the HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Germany, DE). The FDA issued a Cleared decision on July 29, 1993 after a review of 248 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2500 - 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K925910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1992
Decision Date July 29, 1993
Days to Decision 248 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
108d slower than avg
Panel avg: 140d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2500
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 - KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

All 29
Devices cleared under the same product code (KLK) and FDA review panel - the closest regulatory comparables to K925910.
SIEMENS SC9000/SC9015 TCP02/C02 MODULE
K980287 · Siemens Medical Solutions USA, Inc. · Aug 1998
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
K924709 · Air-Shields, Inc. · Jan 1996
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
K893133 · Mennen Medical, Inc. · Jul 1989
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR
K870805 · Novametrix Medical Systems, Inc. · May 1987
515A NEO-TRAK NEONATAL MONITOR
K861861 · Ge Medical Systems Information Technologies · Jul 1986
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
K860124 · Mennen Medical, Inc. · May 1986