Cleared Traditional

K070985 - AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC

K070985 is an FDA 510(k) clearance for AESCULON CHF, manufactured by Osypka Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K070985 · Osypka Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K070985

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
Combination Product No
PCCP Authorized No
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.

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 75
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K070985.
ICON, MODEL C3
K082242 · Osypka Medical, Inc. · Oct 2008
AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
K081035 · Osypka Medical, Inc. · May 2008
PHYSIOFLOW SYSTEM
K060387 · Vasocom, Inc. · Apr 2008
CHEETAH RELIANT, CHEETAH ACTIVE
K072662 · Cheetah Medical, Inc. · Jan 2008
BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100
K070156 · Cardiodynamics International Corp. · Sep 2007
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM
K070500 · Ni Medical · Jul 2007
K070985 · AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
Download PDF FDA Summary Osypka Medical, Inc.