Cleared Traditional

K853706 - BOMED-CDM

K853706 is an FDA 510(k) clearance for BOMED-CDM, manufactured by Bomed Medical Mfr., Ltd.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K853706 · Bomed Medical Mfr., Ltd. · Cardiovascular device
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Apr 1986
Decision
222d
Days
Class 2
Risk

K853706 is an FDA 510(k) clearance for the BOMED-CDM. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Bomed Medical Mfr., Ltd. (Irvine, US). The FDA issued a Cleared decision on April 14, 1986 after a review of 222 days - an extended review 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: 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 Bomed Medical Mfr., Ltd. devices

FDA 510(k) Submission Details - K853706

510(k) Number K853706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1985
Decision Date April 14, 1986
Days to Decision 222 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 125d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DSB Plethysmograph, Impedance

All 54
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K853706.
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