Cleared Traditional

K070985 - AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC (FDA 510(k) Clearance)

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

K070985 · Osypka Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
301d
Days
Class 2
Risk

K070985 is an FDA 510(k) clearance for the AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Osypka Medical, Inc. (La Jolla, US). The FDA issued a Cleared decision on February 1, 2008 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 870.2770 - 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. 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 Osypka Medical, Inc. devices

Submission Details

510(k) Number K070985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2007
Decision Date February 01, 2008
Days to Decision 301 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
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.

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.

Regulatory Peers - DSB Plethysmograph, Impedance

All 113
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K070985.
BCM2-Body Composition Monitor
K250634 · Fresenius Medical Care Renal Therapies Group, LLC · Nov 2025
Re:Balans
K243727 · Mode Sensors AS · Oct 2025
Edema Guard Monitor (EGM) CardioSet-001
K250922 · Cardioset Medical , Ltd. · Sep 2025
SOZO Pro
K232089 · ImpediMed Limited · Oct 2023
Zynex Monitoring System, Model CM-1600
K223217 · Zynex Medical, Inc. · Jun 2023
Bodyport Cardiac Scale
K211585 · Bodyport, Inc. · Jul 2022