Cleared Traditional

K901819 - MODEL 78834C NEONATAL PULSE OXIMETER (S...

K901819 is the FDA 510(k) clearance for MODEL 78834C NEONATAL PULSE OXIMETER (S... by Hewlett-Packard Co.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K901819 · Hewlett-Packard Co. · Anesthesiology device
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Jul 1990
Decision
86d
Days
Class 2
Risk

K901819 is an FDA 510(k) clearance for the MODEL 78834C NEONATAL PULSE OXIMETER (SAO2). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Germany, DE). The FDA issued a Cleared decision on July 18, 1990 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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

Submission Details

510(k) Number K901819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1990
Decision Date July 18, 1990
Days to Decision 86 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
54d faster than avg
Panel avg: 140d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 407
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K901819.
MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA
K902779 · S & W Medico Teknik · Sep 1990
COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC
K902758 · Cobe Laboratories, Inc. · Aug 1990
TYPE 9293 INTERFACE PULSEOX
K896738 · S & W Medico Teknik · Aug 1990
PULSE OXIMETRY MODULE
K901071 · Marquette Electronics, Inc. · Jun 1990
HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL
K901774 · Mennen Medical, Inc. · May 1990
OXYTRAK(TM) PULSE OXIMETER
K894100 · Critikon Company, LLC · May 1990