Cleared Traditional

K863857 - PULSE-OX

K863857 is an FDA 510(k) clearance for PULSE-OX, manufactured by Life Design Systems, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K863857

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
Combination Product No
PCCP Authorized No
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.

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 507
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K863857.
OHMEDA BIOX 3760 PULSE OXIMETER
K874104 · Ohmeda Medical · Dec 1987
EDENTEC MULTI-CHANNEL RECORDER
K873081 · Edentec Corp. · Nov 1987
MODEL 7200A WITH PULSE OXIMETRY
K873065 · Puritan Bennett Corp. · Oct 1987
OHMEDA BIOX 3740 PULSE OXIMETER
K872772 · Ohmeda Medical · Oct 1987
NOVAMETRIX MODEL 505 PULSE OXIMETER
K873078 · Novametrix Medical Systems, Inc. · Sep 1987
OXIMETRY MODULE
K872626 · Marquette Electronics, Inc. · Sep 1987