Cleared Traditional

K103637 - ERKA. PERFECT-ANEROID

K103637 is an FDA 510(k) clearance for ERKA. PERFECT-ANEROID, manufactured by Erka Kallmeyer Medizintechnik GmbH. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K103637 · Erka Kallmeyer Medizintechnik GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
177d
Days
Class 2
Risk

K103637 is an FDA 510(k) clearance for the ERKA. PERFECT-ANEROID. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Erka Kallmeyer Medizintechnik GmbH (Bad Toelz, Bavaria, DE). The FDA issued a Cleared decision on June 8, 2011 after a review of 177 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - 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 Erka Kallmeyer Medizintechnik GmbH devices

FDA 510(k) Submission Details - K103637

510(k) Number K103637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2010
Decision Date June 08, 2011
Days to Decision 177 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 125d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DXQ Device Classification - Class 2, Special Controls

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
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 Consultant

Tuv Sud America, Inc.
NORBERT STUIBER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXQ Blood Pressure Cuff

All 132
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K103637.
BLOOD PRESSURE MONITOR WITH STETHOSCOPE
K122259 · Hangzhou Reli-On Co., Ltd. · Sep 2012
UNIMED DISPOSABLE BLOOD PRESSURE CUFF
K120364 · Unimed Medical Supplies, Inc. · May 2012
UNIMED BLOOD PRESSURE CUFF
K112544 · Unimed Medical Supplies, Inc. · Nov 2011
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
K071244 · Medline Industries, Inc. · Mar 2008
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
K070060 · Welch Allyn, Inc. · Dec 2007
ALL PURPOSE CUFF, MODEL 222APC
K051904 · Suntech Medical, Inc. · Sep 2005