Cleared Traditional

K090664 - DEVON ACCUBP CUFF

K090664 is an FDA 510(k) clearance for DEVON ACCUBP CUFF, manufactured by Devon Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K090664 · Devon Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
10d
Days
Class 2
Risk

K090664 is an FDA 510(k) clearance for the DEVON ACCUBP CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Devon Medical, Inc. (King Of Prussia, US). The FDA issued a Cleared decision on March 23, 2009 after a review of 10 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K090664

510(k) Number K090664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2009
Decision Date March 23, 2009
Days to Decision 10 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
115d faster than avg
Panel avg: 125d · This submission: 10d
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

Regulatory Technology Services, LLC
MARK JOB

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 198
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K090664.
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100
K092245 · Honsun (Nantong) Co., Ltd. · Oct 2009
LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX
K092604 · Trimline Medical Products Corp. · Oct 2009
CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE
K090014 · Caremate Medical Device Co., Ltd. · Apr 2009
VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES
K082630 · Zefon Intl. · Dec 2008
DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100
K080854 · Suntech Medical, Inc. · Oct 2008
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A
K082542 · Cardicare Company, Ltd. · Sep 2008
K090664 · DEVON ACCUBP CUFF
Download PDF FDA Summary Devon Medical, Inc.