Cleared Traditional

BO MED BIA (K811999) - FDA 510(k) Clearance

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

K811999 · Bomed Medical Mfr., Ltd. · Cardiovascular device
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Aug 1981
Decision
51d
Days
Class 2
Risk

K811999 is an FDA 510(k) clearance for the BO MED BIA. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Bomed Medical Mfr., Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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 Bomed Medical Mfr., Ltd. devices

Submission Details

510(k) Number K811999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1981
Decision Date August 31, 1981
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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.