Cleared Traditional

K012444 - ABN ANEROID SPHYGMOMANOMETER

K012444 is the FDA 510(k) clearance for ABN ANEROID SPHYGMOMANOMETER by Pt. Sugih Instrumendo Abadi. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K012444 · Pt. Sugih Instrumendo Abadi · Cardiovascular device
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Aug 2001
Decision
15d
Days
Class 2
Risk

K012444 is an FDA 510(k) clearance for the ABN ANEROID SPHYGMOMANOMETER. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Pt. Sugih Instrumendo Abadi (Hauppauge, US). The FDA issued a Cleared decision on August 16, 2001 after a review of 15 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.

View all Pt. Sugih Instrumendo Abadi devices

Submission Details

510(k) Number K012444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2001
Decision Date August 16, 2001
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 74
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K012444.
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
K023356 · Card Guard Scientific Survival , Ltd. · Jan 2003
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
K022482 · Ge Medical Systems Information Technologies · Aug 2002
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
K012455 · Welch Allyn, Inc. · Aug 2001
CLEEN-ABLE
K994044 · Vital Signs, Inc. · Feb 2000
CUFF-ABLE PLUS
K990412 · Vital Signs, Inc. · Sep 1999
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
K991525 · Deroyal Industries, Inc. · Jul 1999