Cleared Traditional

K863857 - PULSE-OX

K863857 is the FDA 510(k) clearance for PULSE-OX by Life Design Systems, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 370-day FDA review.

K863857 · Life Design Systems, Inc. · Anesthesiology device
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Oct 1987
Decision
370d
Days
Class 2
Risk

K863857 is an FDA 510(k) clearance for the PULSE-OX. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Life Design Systems, Inc. (Carrollton, US). The FDA issued a Cleared decision on October 7, 1987 after a review of 370 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 Life Design Systems, Inc. devices

Submission Details

510(k) Number K863857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1986
Decision Date October 07, 1987
Days to Decision 370 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
230d slower than avg
Panel avg: 140d · This submission: 370d
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 249
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K863857.
OHMEDA 4700 OXICAP MONITOR
K873199 · Ohmeda Medical · Feb 1988
OHMEDA BIOX 3760 PULSE OXIMETER
K874104 · Ohmeda Medical · Dec 1987
MODEL 7200A WITH PULSE OXIMETRY
K873065 · Puritan Bennett Corp. · Oct 1987
OHMEDA BIOX 3740 PULSE OXIMETER
K872772 · Ohmeda Medical · Oct 1987
OXIMETRY MODULE
K872626 · Marquette Electronics, Inc. · Sep 1987
PB240 PATIENT MONITOR/PULSE OXIMETER
K871864 · Puritan Bennett Corp. · Jun 1987