Cleared Traditional

K811147 - VITA-STAT MODEL 9000-A

K811147 is the FDA 510(k) clearance for VITA-STAT MODEL 9000-A by Vita-Stat. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K811147 · Vita-Stat · Cardiovascular device
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Jun 1981
Decision
64d
Days
Class 2
Risk

K811147 is an FDA 510(k) clearance for the VITA-STAT MODEL 9000-A. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Vita-Stat (Mchenry, US). The FDA issued a Cleared decision on June 30, 1981 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vita-Stat devices

Submission Details

510(k) Number K811147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1981
Decision Date June 30, 1981
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 13
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K811147.
AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01
K925899 · Welch Allyn, Inc. · May 1993
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
K863042 · Siemens Medical Solutions USA, Inc. · Jan 1987
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · Hewlett-Packard Co. · Oct 1982
MODEL 1100 SPHYGMOMANOMETER
K811208 · Y · May 1981
PERIPHERAL PULSE FUNCTION BLOCKS
K810171 · Honeywell, Inc. · Feb 1981
PRESSURE FUNCTION BLOCKS
K810172 · Honeywell, Inc. · Feb 1981