Cleared Traditional

K900001 - COROMETRICS MODEL 556 NEONATAL MONITOR

K900001 is an FDA 510(k) clearance for COROMETRICS MODEL 556 NEONATAL MONITOR, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K900001 · Ge Medical Systems Information Technologies · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
331d
Days
Class 2
Risk

K900001 is an FDA 510(k) clearance for the COROMETRICS MODEL 556 NEONATAL MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K900001

510(k) Number K900001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1990
Decision Date November 29, 1990
Days to Decision 331 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
191d slower than avg
Panel avg: 140d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K900001.
MODEL 8604-FO PULSE OXIMETER
K910001 · Nonin Medical, Inc. · Jul 1991
SATLITE PLUS PULSE OXIMETER
K905140 · Datex Division Instrumentarium Corp. · May 1991
AP-860PA NIBP MODULE
K910629 · Nihon Kohden America, Inc. · May 1991
HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE
K903523 · Hewlett-Packard Co. · Oct 1990
MODEL 90421 FLEXPORT INTERFACE
K903702 · Spacelabs, Inc. · Oct 1990
MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA
K902779 · S & W Medico Teknik · Sep 1990