Cleared Special

K152801 - ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT

K152801 is an FDA 510(k) clearance for ULTRACHECK SPACELABS ABP CUFF-CHILD, manufactured by Statcorp Medical. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Special 510(k) pathway after a 29-day FDA review.

K152801 · Statcorp Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
29d
Days
Class 2
Risk

K152801 is an FDA 510(k) clearance for the ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADUL.... Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Statcorp Medical (Jacksonville, US). The FDA issued a Cleared decision on October 27, 2015 after a review of 29 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. 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 - K152801

510(k) Number K152801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2015
Decision Date October 27, 2015
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 198
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K152801.
Disposable Blood Pressure Cuff
K152465 · Shenzhen Vistar Medical Supplies Co., Ltd. · Oct 2015
Reusable Blood Pressure Cuff
K152468 · Shenzhen Vistar Medical Supplies Co., Ltd. · Oct 2015
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
K152363 · Philips Medical Systems · Oct 2015
Aneroid Sphygmomanometer
K151246 · Jiaxing Zhongfa Medical Products Co., Ltd. · Jun 2015
Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
K151290 · Xuzhou Maicuff Technology Co., Ltd. · Jun 2015
Minhua Disposable Blood Pressure Cuff
K143728 · Suzhou Minhua Medical Apparatus · May 2015
K152801 · ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT
Download PDF FDA Summary Statcorp Medical