Cleared Traditional

K843010 - BP-800

K843010 is an FDA 510(k) clearance for BP-800, manufactured by Pollenex Associated Mills, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K843010 · Pollenex Associated Mills, Inc. · Cardiovascular device
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May 1985
Decision
301d
Days
Class 2
Risk

K843010 is an FDA 510(k) clearance for the BP-800. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Pollenex Associated Mills, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 29, 1985 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pollenex Associated Mills, Inc. devices

FDA 510(k) Submission Details - K843010

510(k) Number K843010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1984
Decision Date May 29, 1985
Days to Decision 301 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 125d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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 905
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K843010.
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