Cleared Traditional

K895987 - KELLER PULSE OXIMETER - KMS 850

K895987 is an FDA 510(k) clearance for KELLER PULSE OXIMETER - KMS 850, manufactured by Keller Medical Specialties Products, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K895987 · Keller Medical Specialties Products, Inc. · Anesthesiology device
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Feb 1990
Decision
133d
Days
Class 2
Risk

K895987 is an FDA 510(k) clearance for the KELLER PULSE OXIMETER - KMS 850. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Keller Medical Specialties Products, Inc. (Antioch, US). The FDA issued a Cleared decision on February 22, 1990 after a review of 133 days - within the typical 510(k) review window.

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. 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 Keller Medical Specialties Products, Inc. devices

FDA 510(k) Submission Details - K895987

510(k) Number K895987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1989
Decision Date February 22, 1990
Days to Decision 133 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 140d · This submission: 133d
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 549
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K895987.
OXIMAX 700
K900866 · Pace Tech, Inc. · Apr 1990
OXIMAX 100
K900843 · Pace Tech, Inc. · Mar 1990
MODEL 8500 HAND HELD PULSE OXIMETER
K893221 · Nonin Medical, Inc. · Feb 1990
NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER
K893643 · Novametrix Medical Systems, Inc. · Oct 1989
ESCORT PULSE OXIMETRY OPTION
K892120 · Medical Data Electronics · Sep 1989
MINIMON 7137B PATIENT MONITOR
K895425 · Kontron Instruments, Inc. · Sep 1989