Cleared Abbreviated

K092604 - LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX

K092604 is an FDA 510(k) clearance for LARGE FACE ANEROID SPHYGMOMANOMETER, manufactured by Trimline Medical Products Corp.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Abbreviated 510(k) pathway after a 57-day FDA review.

K092604 · Trimline Medical Products Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
57d
Days
Class 2
Risk

K092604 is an FDA 510(k) clearance for the LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MOD.... Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Trimline Medical Products Corp. (Branchburg, US). The FDA issued a Cleared decision on October 21, 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Trimline Medical Products Corp. devices

FDA 510(k) Submission Details - K092604

510(k) Number K092604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2009
Decision Date October 21, 2009
Days to Decision 57 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Standards-based clearance path.

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 144
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K092604.
UNIMED DISPOSABLE BLOOD PRESSURE CUFF
K120364 · Unimed Medical Supplies, Inc. · May 2012
UNIMED BLOOD PRESSURE CUFF
K112544 · Unimed Medical Supplies, Inc. · Nov 2011
ERKA. PERFECT-ANEROID
K103637 · Erka Kallmeyer Medizintechnik GmbH · Jun 2011
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