Cleared Traditional

K092999 - NBP CUFF

K092999 is an FDA 510(k) clearance for NBP CUFF, manufactured by Draeger Medical AG & Co. KG. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K092999 · Draeger Medical AG & Co. KG · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
57d
Days
Class 2
Risk

K092999 is an FDA 510(k) clearance for the NBP CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Draeger Medical AG & Co. KG (Telford, US). The FDA issued a Cleared decision on November 24, 2009 after a review of 57 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 - K092999

510(k) Number K092999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2009
Decision Date November 24, 2009
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - DXQ Blood Pressure Cuff

All 166
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K092999.
DISPOSABLE BLOOD PRESSURE CUFF
K102823 · Wuxi Medical Instrument Factory · Jan 2011
HEINE GAMMA G7
K101892 · Heine Optotechnik GmbH & Co. KG · Aug 2010
SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS
K101972 · Solaris Medical Technology, Inc. · Jul 2010
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