Cleared Special

K081035 - AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2

K081035 is an FDA 510(k) clearance for AESCULON C2, manufactured by Osypka Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Special 510(k) pathway after a 49-day FDA review.

K081035 · Osypka Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
49d
Days
Class 2
Risk

K081035 is an FDA 510(k) clearance for the AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESC.... 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 May 30, 2008 after a review of 49 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K081035

510(k) Number K081035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2008
Decision Date May 30, 2008
Days to Decision 49 days
Submission Type Special
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
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

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 K081035.
CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS
K090602 · Cardiodynamics International Corp. · May 2009
CHEETAH RELIANT
K083093 · Cheetah Medical, Inc. · Dec 2008
ICON, MODEL C3
K082242 · Osypka Medical, Inc. · Oct 2008
PHYSIOFLOW SYSTEM
K060387 · Vasocom, Inc. · Apr 2008
AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
K070985 · Osypka Medical, Inc. · Feb 2008
CHEETAH RELIANT, CHEETAH ACTIVE
K072662 · Cheetah Medical, Inc. · Jan 2008
K081035 · AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
Download PDF FDA Summary Osypka Medical, Inc.