Cleared Traditional

LIFESTAT 100 (K853561) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853561 · Physio-Control Corp. · Cardiovascular device
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Jun 1986
Decision
287d
Days
Class 2
Risk

K853561 is an FDA 510(k) clearance for the LIFESTAT 100. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Physio-Control Corp. (Redmond, US). The FDA issued a Cleared decision on June 9, 1986 after a review of 287 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Physio-Control Corp. devices

Submission Details

510(k) Number K853561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date June 09, 1986
Days to Decision 287 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 125d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 286
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K853561.
MODIFIED STBP-680
K863891 · Quinton, Inc. · Feb 1987
2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF
K861987 · Ohmeda Medical · Feb 1987
NBP 488, TPR 488
K861856 · Siemens Medical Solutions USA, Inc. · Dec 1986
MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR
K854370 · Nihon Kohden America, Inc. · Apr 1986
WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
K852574 · Welch Allyn, Inc. · Mar 1986
MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
K844252 · Medtronic Vascular · Jun 1985